Obesity is considered the epidemic of the 21st century. Obesity is a multifactorial disease and the most important risk factors are poor diet and sedentary lifestyle. An excessive body weight contributes to increase the risk of suffering from other diseases and mortality rates. Therefore, the prevention and control of excessive body weight as well as its comorbidities are essential. In this sense, the principal strategy to treat obesity is to improve dietary habits and increase physical activity. However, the rate of obesity continues rising. In order to deal with this problem, new strategies to combat obesity are being investigated, such as the investigation of new bioactive compounds with satiating capacity that can be included in healthy dietary patterns to improve adherence to dietary treatments. Considering this background, the main objective of this research is to assess the effect of daily consumption of protein rich bars accompanied by healthy dietary recommendations on weight loss of overweight/obese adult men and women.
This study is designed as a 12-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old. All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research in the University of Navarra for the screening visit and 4 more times during the intervention (week 1, 4, 8 and 12 of study). Screening visit: evaluation of the inclusion criteria. Volunteers who meet the inclusion criteria are provided with a feces collection kit, urine collection kit, food frequency questionnaire, visual analogue scale and minnesota physical activity questionnaire. Moreover, they are randomly assigned to one of the two intervention groups: * Control group: healthy dietary recommendations. * Experimental group: healthy dietary recommendations + 2 protein rich bars/day Clinical investigation day 1 (week 1): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in screening visit. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. After that, volunteer is provided with healthy dietary recommendations only or dietary recommendations and protein rich bars, depending on the allocated intervention group. Moreover, volunteer is provided with visual analogue scale to be completed for the Clinical investigation day 2. Clinical investigation day 2 (week 4): The volunteer attend the Nutrition Intervention Unit. The volunteer is asked to provide the visual analogue scale. Then, gastrointestinal symptoms questionnaire is completed and the adherence to the study is assessed. Then, body weight and blood pressure are measured. Volunteer is provided with fece and urine collection kits, food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale, to be completed for the Clinical investigation day 3. Finally, volunteers allocated in experimental group are provided with protein rich bars. Clinical investigation day 3 (week 8): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 2. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. Volunteer is provided with fece and urine collection kits, as well as food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale to be completed for the Clinical investigation day 4. Finally, volunteers allocated in experimental group are provided with protein rich bars. Clinical investigation day 4 (week 12): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 3. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Volunteers allocated in the experimental group will receive dietary recommendations and 2 protein enriched bars per day to be eaten 45 minutes before lunch and dinner.
Volunteers allocated in the experimental group will receive dietary recommendations.
Center for Nutrition Research. University of Navarra
Pamplona, Navarre, Spain
Change of weight from baseline to week 4 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of weight from baseline to week 8 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of weight from baseline to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of weight from week 4 to week 8 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 3(after 8 weeks of intervention).
Change of weight from week 4 to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of weight from week 8 to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat percentage from baseline to week 8 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat percentage from baseline to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat percentage from week 8 to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from baseline to week 8 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat kilograms from baseline to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from week 8 to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
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Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from baseline to week 8 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body muscle mass from baseline to week 12 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from week 8 to week 12 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from baseline to week 8 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body lean mass from baseline to week 12 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from week 8 to week 12 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from baseline to week 8 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water mass from baseline to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from week 8 to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from baseline to week 8 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water percentage from baseline to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from week 8 to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from baseline to week 8 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mass from baseline to week 12 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from week 8 to week 12 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Height at baseline
Height of participants will be measured by stadiometer and reported in meters.
Time frame: The Time Frame contains one time point: screening visit.
Change of waist circumference from baseline to week 8
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of waist circumference from baseline to week 12
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of waist circumference from week 8 to week 12
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from baseline to week 8
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hip circumference from baseline to week 12
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from week 8 to week 12
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from baseline to week 8
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of neck circumference from baseline to week 12
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from week 8 to week 12
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from baseline to week 4
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of systolic blood pressure from baseline to week 8
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from baseline to week 12
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from week 4 to week 8
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from week 8 to week 12
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from baseline to week 4
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of diastolic blood pressure from baseline to week 8
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of diastolic blood pressure from baseline to week 12
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from week 4 to week 8
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of diastolic blood pressure from week 8 to week 12
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of heart rate from baseline to week 4
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of heart rate from baseline to week 8
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of heart rate from baseline to week 12
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of heart rate from week 4 to week 8
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of heart rate from week 8 to week 12
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in percentage from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat mass in percentage from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in percentage from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in kg from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat mass in kg from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in kg from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of lean mass in kg from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from baseline to week 12 (densitometry)
Change of lean mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral concentration from baseline to week 8 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral concentration from baseline to week 12 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral concentration from week 8 to week 12 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density from baseline to week 8 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density from baseline to week 12 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density from week 8 to week 12 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of visceral mass from baseline to week 8 (densitometry)
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of visceral mass from baseline to week 12 (densitometry)
Change of visceral mass density of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of visceral mass from week 8 to week 12 (densitometry)
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of L1-L4 bone mineral density from baseline to week 8 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of L1-L4 bone mineral density from baseline to week 12 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of L1-L4 bone mineral density from week 8 to week 12 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total bone mineral density of femur from baseline to week 8 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of total bone mineral density of femur from baseline to week 12 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total bone mineral density of femur from week 8 to week 12 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of femur neck from baseline to week 8 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density of femur neck from baseline to week 12 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of femur neck from week 8 to week 12 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of radius from baseline to week 8 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density of radius from baseline to week 12 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of radius from week 8 to week 12 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of glucose concentration from baseline to week 8
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of glucose concentration from baseline to week 12
Change of glucose levels of participants in fasting condition will be analyzed by absorptiometry and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of glucose concentration from week 8 to week 12
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total cholesterol concentration from baseline to week 8
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of total cholesterol concentration from baseline to week 12
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total cholesterol concentration from week 8 to week 12
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of HDL cholesterol concentration from baseline to week 8
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of HDL cholesterol concentration from baseline to week 12
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of HDL cholesterol concentration from week 8 to week 12
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of LDL cholesterol concentration from baseline to week 8
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of LDL cholesterol concentration from baseline to week 12
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of LDL cholesterol concentration from week 8 to week 12
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of triglyceride concentration from baseline to week 8
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of triglyceride concentration from baseline to week 12
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of triglyceride concentration from week 8 to week 12
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of alanine aminotransferase concentration from baseline to week 8
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of alanine aminotransferase concentration from baseline to week 12
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of alanine aminotransferase concentration from week 8 to week 12
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of aspartate aminotransferase concentration from baseline to week 8
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of aspartate aminotransferase concentration from baseline to week 12
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of aspartate aminotransferase concentration from week 8 to week 12
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of homocysteine concentration from baseline to week 8
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of homocysteine concentration from baseline to week 12
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of homocysteine concentration from week 8 to week 12
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of C-reactive protein concentration from baseline to week 8
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of C-reactive protein concentration from baseline to week 12
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of C-reactive protein concentration from week 8 to week 12
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hemogram concentration from baseline to week 8
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hemogram concentration from baseline to week 12
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hemogram concentration from week 8 to week 12
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of albumin concentration from baseline to week 8
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of albumin concentration from baseline to week 12
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of albumin concentration from week 8 to week 12
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of creatinine concentration from baseline to week 8
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 8 weeks of intervention).
Change of creatinine concentration from baseline to week 12
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of creatinine concentration from week 8 to week 12
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of physical activity level from baseline to week 8
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of physical activity level from baseline to week 12
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of physical activity level from week 8 to week 12
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of dietary intake from baseline to week 8
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of dietary intake from baseline to week 12
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of dietary intake from week 8 to week 12
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hunger from baseline to week 4
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of hunger from baseline to week 8
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hunger from baseline to week 12
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hunger from week 4 to week 8
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hunger from week 8 to week 12
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of fullness from baseline to week 4
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of fullness from baseline to week 8
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of fullness from baseline to week 12
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of fullness from week 4 to week 8
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of fullness from week 8 to week 12
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of satisfaction sensation from baseline to week 4
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of satisfaction sensation from baseline to week 8
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of satisfaction sensation from baseline to week 12
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of satisfaction sensation from week 4 to week 8
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of satisfaction sensation from week 8 to week 12
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of want to eat something else sensation from baseline to week 4
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of want to eat something else sensation from baseline to week 8
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of want to eat something else sensation from baseline to week 12
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of want to eat something else sensation from week 4 to week 8
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of want to eat something else sensation from week 8 to week 12
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of thirst sensation from baseline to week 4
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of thirst sensation from baseline to week 8
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of thirst sensation from baseline to week 12
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of thirst sensation from week 4 to week 8
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time frame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of thirst sensation from week 8 to week 12
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 4
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 8
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 12
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of gastrointestinal symptoms from week 4 to week 8
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of gastrointestinal symptoms from week 8 to week 12
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Time frame: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Bar acceptance at week 12
Bar acceptance will be analyzed by acceptance questionnaire.
Time frame: The Time Frame contains Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bar consumption record from baseline to week 4
Change of bar consumption will be analyzed by bar consumption record.
Time frame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of bar consumption record from baseline to week 8
Change of bar consumption will be analyzed by bar consumption record.
Time frame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bar consumption record from baseline to week 12
Change of bar consumption will be analyzed by bar consumption record.
Time frame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bar consumption record from week 4 to week 8
Change of bar consumption will be analyzed by bar consumption record.
Time frame: The Time Frame contains Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bar consumption record from week 8 to week 12
Change of bar consumption will be analyzed by bar consumption record.
Time frame: The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change in urine and feces hydroxyproline concentration from baseline to week 8
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Time frame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change in urine and feces hydroxyproline concentration from baseline to week 12
Change of hydroxyproline concentration will be analyzed by colorimetry technique
Time frame: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change in urine and feces hydroxyproline concentration from week 8 to week 12
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Time frame: The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).