Clinical Trials of Five Different Food Supplements With Restriction Diet in Adults (FOODSU)

The Effects of Five Different Food Supplements With Restriction Diet on the Components of the Metabolic Syndrome in Overweight and Obese Adults

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.

Fiber of light Indian plantain, 7 g; glucomannan, 4,3 g; Inulin 2,5 g; Apple fiber, 1g; Choline, bitartrate 90 mg; Apple pectin,50 mg; Inositol, 40 mg

POWDER: Plantain fibre 10 g; Inulin, 2 g; Apple fibre, 1,5 g; Root of pellitory, 500 mg; Apple pectin, 450 mg CAPSULE: Pumpkin seed extract, 300 mg; Garlic extract odourless, 300 mg; Artichoke leaf extract, 150 mg; Cumin seed extract, 150 mg; Peppermint leaf extract, 150 mg; Anise seed extract, 150 mg; Curcuma rhizome extract, 150 mg; Vitamin C, 42 mg; Zinc (in gluconate),10 mg; Vitamin B6, 1,5 mg

CAPSULE 1:L-arginine, 100 mg; Choline bitartrate, 100 mg; L-carnosine, 100 mg; L-taurine, 100 mg; Soy lecithin, 50 mg; R-alfa lipoic acid,10 mg; Vitamin B6,2 mg; Folic acid, 200 µg; Vitamin D3, 5 µg; Vitamin B12, 2 µg CAPSULE 2: Schisandra fruit extract, 400 mg; Milk thistle fruit extract associated with phospholipids, 200 mg; Grape seed extract associated with phospholipids, 50 mg; Grape seed extract (Vitis vinifera),50 mg

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

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

Changes in percentage of body fat from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

Changes in body weight (in kilograms) from baseline to week eight measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA

Changes in waist circumference (in centimetres) from baseline to week eight measured with a flexible tape measure

Changes in muscle mass (in kilograms) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA

Changes in visceral fat rating (index) from baseline to week eight measured with bioelectrical bioelectrical impedance analysis (BIA) Tanita MC-980MA

Changes in total cholesterol, LDL cholesterol, HDL cholesterol and triacylglycerides measured by biochemical analyzer Cobass

Changes in antioxidative potential determined by 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical measurements.

Inclusion Criteria: BMI > 25 kg/m2 BMI > 25 kg/m2 personally signed and dated informed consent form ability to understand and willingness to comply with all protocols required visits assessments and interventions Exclusion Criteria: use of dietary supplements use of medication for any component of metabolic syndrome presence of inflammatory and/or autoimmune disorders pregnancy or lactating