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

Study 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

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)

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Drug: Polyglucosamine L112
* Other: Placebo


Participation Criteria
=================
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 Epilepsy Past or current malignancies Intellectual disability Significant motor disability Drug abuse Autoimmune diseases Symptomatic cholelithiasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Product<br>75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg | Drug: Polyglucosamine L112<br>* Polyglucosamine; Ascorbic Acid; Tartaric Acid<br>* Other names: Formoline L112;|
| Placebo Comparator: Placebo<br>75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg | Other: Placebo<br>* Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG) | 3-month treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglycerides | To evaluate the effect of PG administration on triglycerides plasma levels | 3-month treatment | 
| Cholesterol | To evaluate the effect of PG administration on total cholesterol plasma levels | 3-month treatment | 
| HOMA | To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA | 3-month treatment | 
| Hepatic Enzymes - Renal Functionality | To evaluate the effect of PG administration on transaminases and creatinine | 3-month treatment | 
| BMI | To evaluate the effect of PG administration on BMI | 3-month treatment | 
| Abdominal Circumference | To evaluate the effect of PG administration on the abdominal circumference | 3-month treatment | 
| DXA | To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry) | 3-month treatment | 
| ROS | To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels | 3-month treatment | 
| Antioxidant Serum Capacity | To evaluate the effect of PG administration on serum antioxidant capacity | 3-month treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polyglucosamine, Formoline L112, Medical Device