Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects

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

Inclusion Criteria:

• Signed written informed consent
• Age between 18-65
• Both sexes - mandatory adequate contraceptive method for women in fertility age
• BMI between 25-32 kg/m2 and weigh in > 75 kg, with no previous diet-therapy attempts with at least a 5% weight loss in the last year
• No 3 kg weight fluctuation in the last 3 months
• Beck Depression Inventory (BDI) score < 20
• Binge Eating Scale (BES) score < 27

Exclusion Criteria:

• Shellfish allergy or to any other ingredient in the product
• Previous diet-therapy attempts with at least a 5% weight loss in the last year
• 3 kg weight fluctuation in the last 3 months
• Presumed or confirmed pregnancy
• No contraceptive method for women in fertility age
• Cardiopathies, nephropathies, hepatopathies, bronchopneumopathies, hemopathies dermopathies clinically significant chronic degenerative CNS (Central Nervous System) diseases
• Active peptic ulcer, ulcerative colitis, Crohn disease, celiac disease, inflammatory bowel disease
• Alcoholism
• Epilepsy
• Past or current malignancies
• Intellectual disability
• Significant motor disability
• Drug abuse
• Autoimmune diseases
• Symptomatic cholelithiasis