The main objective of this intervention study is to evaluate the effect of satiating protein and/or fiber bar consumption on weight loss and other osteoarticular and cardiometabolic parameters related to excess weight in subjects with overweight or obesity. To achieve this objective, volunteers will be instructed to consume three bars per day as part of a hypocaloric diet, in accordance with healthy nutritional guidelines, over a 12-week period. The main questions to answer are: * Does the regular consumption of these protein and/or fiber bars help to lose weight? * Does the regular consumption of these protein and/or fiber bars help to improve the osteoarticular health? * Does the regular consumption of these protein and/or fiber bars help to improve the cardiometabolic health? The specific objectives are focused on evaluating the effects of the intervention on the following parameters: * Weight and body composition. * Knee joint range of motion. * Blood biomarkers related to collagen degradation and synthesis, associated with osteoarticular health. * Glycemic and lipid profiles, blood pressure, and biomarkers of kidney, liver, cardiovascular, and inflammatory health. * Changes in joint discomfort (improvement or worsening). * Adherence to the assigned intervention, including both dietary compliance and intake of the study-provided supplement. * Satiety-related variables assessed using a visual analog scale (VAS). * Urinary hydroxyproline and stool samples for metagenomic analysis. * Gastrointestinal health, mental health, quality of life, and physical activity level assessed through validated questionnaires. Target sample size is 144 subjects and participants will be allocated in four different groups: * Group 1 (n=36): hypocaloric diet + protein and fiber supplement. * Group 2 (n=36): hypocaloric diet + protein and fiber supplement. * Group 3 (n=36): hypocaloric diet + fiber supplement. * Group 4 "Placebo group" (n=36): hypocaloric diet + placebo supplement. Participants will attend the nutritional intervention unit at weeks 1, 8, and 12. A follow-up phone call will be conducted at week 4.
Volunteers expressing interest in the study will undergo an initial eligibility assessment, either via telephone interview or by completing an online screening form (Google Form), to verify compliance with the primary inclusion criteria. Candidates meeting these criteria will be invited to attend an information and screening visit, during which the study procedures will be explained in detail and any questions addressed. Individuals who agree to participate will provide written informed consent and will be randomly allocated to one of the four intervention groups. All necessary study materials will be provided at this stage. Participants will attend three scheduled clinical investigation visits: baseline (day 0), mid-intervention (week 8), and post-intervention (week 12). At each visit, anthropometric and body composition measurements will be performed, and blood pressure will be recorded. Biological samples, including blood, urine, and stool, will be collected. In addition, data regarding dietary intake, physical activity levels, sleep patterns, and gastrointestinal symptoms will be obtained through validated questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Participants will consume three satiating compound-enriched bars (formulation 1) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
Participants will consume three satiating compound-enriched bars (formulation 2) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
Participants will consume three satiating compound-enriched bars (formulation 3) daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
Participants will consume three placebo bars daily, 30 minutes before breakfast, lunch, and dinner, as part of a 10% energy-restricted hypocaloric diet for 12 weeks.
Center for Nutrition Research
Pamplona, Navarre, Spain
RECRUITINGBody weight
Weight of participants will be measured by bioimpedance an densitometry and reported in kg
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Height
Height of participants will be measured by stadiometer and reported in cm.
Time frame: Clinical Investigation Day 1
Body mass index
Body mass index will be calculated as follows: weight (kilograms)/ height (m)2
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Waist circumference
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Hip circumference
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Neck circumference
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body fat mass
Body fat of participants will be analyzed by bioimpedance and densitometry and reported in percentage and kilograms.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body lean mass
Body lean mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body muscle mass
Body muscle mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Fat free mass
Fat free mass of participants will be analyzed by densitometry and reported in kilograms.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Visceral fat
Visceral fat of participants will be measured by bioimpedance an densitometry and reported in g.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body water mass
Body water mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms and percentage.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Body bone mass
Body bone mass Body bone mass of participants will be analyzed by bioimpedance and densitometry and reported in kilograms.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Systolic blood pressure
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Diastolic blood pressure
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Heart rate
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in pulses/min.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Total bone mineral density
Total bone mineral density of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Bone mineral density L1-L4
Bone mineral density L1-L4 of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Total bone mineral density femur
Total bone mineral density femur of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Bone mineral density femur neck
Bone mineral density femur neck of participants will be analyzed by densitometry and reported in g/cm2.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Knee articular range
Knee articular range of participants will be measured using a goniometer and performing the chair test.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Grip strength
Grip strength of participants will be measured using a manual dynamometer and reported in kg.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Level of hunger
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 is 100 mm. A reduction in hunger scale means better outcome.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2
Level of fullness
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: Clinical Investigation Day 1, Clinical Investigation Day 2
Level of satisfaction
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: Clinical Investigation Day 1, Clinical Investigation Day 2
Want to eat something else
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: Clinical Investigation Day 1, Clinical Investigation Day 2
Thirst
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: Clinical Investigation Day 1, Clinical Investigation Day 2
Life quality
Life quality of participants will be evaluated by SF-36 questionnaire (36-Item Short Form Survey).
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Depression
Depression will be evaluated using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Anxiety
Anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI), a 40-item self-report questionnaire that includes two subscales: State Anxiety (20 items) and Trait Anxiety (20 items). Each subscale yields scores ranging from 20 to 80, with higher scores indicating greater levels of anxiety.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Osteoarticular health
Osteoarticular health of participants will be measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC), a 24-item self-report questionnaire that assesses pain (range 0-20), stiffness (range 0-8), and physical function (range 0-68). The total score ranges from 0 to 96, with higher scores indicating worse osteoarticular symptoms and functional impairment.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Physical activity
Physical activity will be evaluated using the Physical Activity Questionnaire of the Seguimiento Universidad de Navarra (SUN) cohort, which estimates total physical activity expressed in Metabolic Equivalent of Task hours per week (MET-h/week). Higher values indicate greater levels of physical activity. Participants can also be classified into categories of low, moderate, or high physical activity according to standardized SUN cohort scoring procedures.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Gastrointestinal symptoms
Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Glucose concentration
Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Insulin concentration
Blood insulin concentration will be analyzed after an overnight fast by ELISA kit and reported in μUI/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
HOMA index (Homeostatic Model Assessment Index)
HOMA index will be calculated as follows: HOMA-IR (Homeostatic Model Assessment for Insulin Resistance)= \[fasting glucose (mmol/L) x fasting insulin (μU/ml)\] / 22.5.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Total cholesterol
Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
HDL cholesterol
Blood HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
LDL cholesterol
LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Triglyceride concentration
Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Alanine aminotransferase
Alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI/L.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Aspartate aminotransferase
Aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI/L.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Gamma-glutamyl transferase
Gamma-glutamyl transferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in UI/L.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Fatty liver Index (FLI)
Fatty liver Index will be calculated as follows FLI = (e 0.953 × ln (triglycerides) + 0.139 × BMI + 0.718 × ln (ggt) + 0.053 × waist circumference - 15.745)/ (1 + e 0.953 × ln (triglycerides) + 0.139 × BMI + 0.718 × ln (ggt) + 0.053 × waist circumference - 15.745) × 100
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Fructosamine concentration
Blood fructosamine concentration will be analyzed after an overnight fast by ELISA kit and reported in µg/L.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Leptine
Blood leptine concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/ml
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Adiponectin
Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit and reported in ng/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Homocysteine
Blood homocysteine concentration will be analyzed after an overnight fast by biochemical autoanalyzer and reported in μmol/L.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
MCP1 (Monocyte Chemoattractant Protein-1)
Blood MCP1 concentration will be analyzed after an overnight fast by ELISA kit and reported in pg/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
TNF-alpha (tumor necrosis factor alpha)
TNF-alpha will be analyzed after an overnight fast by ELISA kit and reported in pg/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Interleukin 6 (IL6)
Blood IL6 concentration will be analyzed after an overnight fast by ELISA kit and reported in pg/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
C Reactive protein (CRP)
Blood CRP concentration will be analyzed after an overnight fast by ELISA kit and reported in mg/L
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Blood glycated hemoglobin
Fasting blood glycated hemoglobin will be reported in percentage.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Plasma CTX-II levels (C-terminal telopeptide of type II collagen)
Plasma CTX-II levels will be analyzed after an overnight fast by ELISA kit and reported in ng/ml
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Plasma C2C levels (Cartilage Collagen Neoepitope)
Plasma C2C levels will be analyzed after an overnight fast by ELISA kit and reported in ng/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Plasma CP2 levels (type II procollagen carboxy-propeptide)
Plasma CP2 levels will be analyzed after an overnight fast by ELISA kit and reported in ng/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3.
Albumin concentration
Albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in mg/dl.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Creatinine concentration
Creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in mg/dl.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Hydroxyproline
Urine hydroxyproline concentration will be analyzed after an overnight fast by colorimetry technique and reported in mg/ml.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Blood untargeted metabolomics
Untargeted metabolites will be expressed and analyzed in plasma and serum according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Urine untargeted metabolomics
Untargeted metabolomics will be expressed and analyzed in urine according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Lipidomic
Lipidomic will be expressed and analyzed in plasma and serum according to their intensity measured in arbitrary units (UA), which carries a direct relation with its concentration.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Dietary Intake (Energy and Nutrients)
Dietary intake will be assessed using the Food Frequency Questionnaire (FFQ). Outcomes will include energy intake (kcal/day), macronutrient intake (g/day), and micronutrient intake (mg/day or µg/day).
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Mediterranean Diet Adherence
Adherence to the Mediterranean dietary pattern will be evaluated using the Mediterranean Diet Adherence Questionnaire, with scores ranging from 0 to 14 points. Higher scores indicate greater adherence to the Mediterranean diet.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2 and Clinical Investigation Day 3
Snacking frequency
Snacking behavior will be recorded using a daily snacking record. Results will be expressed as number of snacks per day.
Time frame: Clinical Investigation Day 1, Clinical Investigation Day 2, and Clinical Investigation Day 3
Adherence to bars consumption
Adherence will be assessed using the bars consumption record form.
Time frame: Clinical Investigation Day 2 and Clinical Investigation Day 3
Acceptance of bars
Acceptance will be assessed using the acceptance consumption record form.
Time frame: Clinical Investigation Day 3
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