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)
Overview
- Phase
- Phase 4
- Intervention
- Polyglucosamine L112
- Conditions
- Weight Loss
- Sponsor
- Certmedica International GmbH
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Weight Loss
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
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
- •Past or current malignancies
- •Intellectual disability
Arms & Interventions
Product
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg
Intervention: Polyglucosamine L112
Placebo
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg
Intervention: Placebo
Outcomes
Primary Outcomes
Weight Loss
Time Frame: 3-month treatment
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
Secondary Outcomes
- Triglycerides(3-month treatment)
- Cholesterol(3-month treatment)
- HOMA(3-month treatment)
- Hepatic Enzymes - Renal Functionality(3-month treatment)
- BMI(3-month treatment)
- Abdominal Circumference(3-month treatment)
- DXA(3-month treatment)
- ROS(3-month treatment)
- Antioxidant Serum Capacity(3-month treatment)