Weight Loss Clinical Trial
Official title:
Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects: POSO Study (Polyglucosamine and Overweight)
The purpose of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
The primary objective of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage. The secondary objectives of the study are: - to evaluate the effect of supplementation on blood triglyceride levels - to evaluate the effect of supplementation on blood levels of Total Cholesterol (CT), LDL, and HDL - to evaluate the effect of supplementation on glucose, insulin, insulin resistance assessed by calculating the Homeostatic metabolic assessment (HOMA) - to evaluate the effect of supplementation on liver enzymes (transaminases) and renal function (creatinine) - to evaluate the effect of supplementation on BMI (Body Mass Index) - to evaluate the effect of supplementation on the abdominal circumference - to evaluate the effect of supplementation on body composition evaluated by dual X-ray densitometer (DXA) - to evaluate the effect of supplementation on the serum levels of reactive oxygen species - to evaluate the effect of supplementation on serum antioxidant capacity ;
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