In recent years, dietary supplement are of great interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical and anthropometric parameters.
The incidence of obesity has been rapidly increasing, and this condition has become a major public health threat, since it is strongly linked with increased risk for several diseases including type 2 diabetes, cardiovascular disease, cancer and brain aging. Obesity and overweight are chronic disorders of multifactorial origin that are characterized by high oxidative status and by low chronic inflammation. Thus far, molecular mechanisms underlying obesity and obesity-related metabolic disorders have not been fully clarified, and effective therapeutic approaches to lower inflammation and oxidative stress are currently of general interest. In recent years, dietary supplement and are of interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical (lipid profile, glucose, C-reactive protein, bilirubin, alanine aminotransferase, etc), and anthropometric parameters (body mass, the percentage of body fat, visceral fat index, etc,...). Food supplements are mainly composed of different fiber and other bioactive compounds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
IP1: 2 softchews 3 times a day before meals with 1-2 glasses of water for eight weeks. OTHER: Placebo
IP2: One bag per day mixed in 200 mL of cold water or tea and consumed immediately, on an empty stomach, half an hour before breakfast for eight weeks. OTHER: Placebo
IP3: One bag per day in the morning, dissolved in a glass of warm water and three capsules per day with a glass of water or tea (one capsule at breakfast, one at lunch and one at dinner) for eight weeks. OTHER:Placebo
University of Primorska, Faculty of Health Sciences
Izola, Slovenia
Change in body fat
Changes in percentage of body fat from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Change in body weight
Changes in body weight (in kilograms) from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Changes in waist circumference
Changes in waist circumference (in centimetres) from baseline to week eight measured with a flexible tape measure
Time frame: eight weeks
Changes in muscle mass
Changes in muscle mass (in kilograms) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Changes in visceral fat rating
Changes in visceral fat rating (index) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA
Time frame: eight weeks
Lipid profile
Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides measured by biochemical analyzer Cobass
Time frame: eight weeks
Blood pressure
Changes in diastolic and systolic blood pressure measured by blood pressure device (Omron M3)
Time frame: eight weeks
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IP4: Twice a day 20 mL half an hour before breakfast and half an hour before dinner for eight weeks. OTHER:Placebo
IP5: Formula 1: One capsule per day at breakfast with a glass of water for eight weeks and Formula 2: Two capsules a day at breakfast and at dinner with a glass of water for eight weeks. OTHER:Placebo
Inflammation
Changes in C-reactive protein levels measured by biochemical analyzer Cobass
Time frame: eight weeks
Antioxidative potential
Changes in antioxidative potential determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical measurements.
Time frame: eight weeks