Polyglucosamine L112 in Overweight and Obese Subjects

Study Overview
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Brief Summary
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This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day 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

Official Title
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Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device Based on Polyglucosamine L112® in a Group of Overweight and Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Polyglucosamine L112
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: weight > 75 Kg absence of previous diet therapy attempts no fluctuation of at least 3 kg in the previous 3 months Beck Depression Inventory score < 20 pt Binge Eating Scale score < 27 pt Exclusion Criteria: allergy to shellfish pregnancy or breast feeding presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease symptomatic cholelithiasis previous or current neoplasms epilepsy obesity secondary to endocrinopathies or genetic syndromes significant motor disability or mental retardation major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), schizophrenia previous history or current diagnosis of drug abuse or alcoholism changing in smoking habits or quitting smoking in the last 6 months current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control formula<br>Excipients and gum arabic in tablet | Combination Product: Placebo<br>* excipients and gum arabic<br>|
| Active Comparator: Experimental formula<br>Polyglucosamine L112 (750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients) | Dietary Supplement: Polyglucosamine L112<br>* 750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on anthropometric measures | Body weight (Kg) | Changes from baseline anthropometric measures at 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on lipid profile | Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl) | Changes from baseline lipid profile at 90 days | 
| Changes on insulin resistance | Homeostasis Model Assessment (pt) for evaluate insulin resistance il > 2,4 | Changes from baseline insulin resistance at 90 days | 
| Changes on Carbohydrate profile | Glycemia (mg/dl) | Changes from baseline Carbohydrate profile at 90 days | 
| Changes on Carbohydrate profile | Insulin (mcU/ml) | Changes from baseline Carbohydrate profile at 90 days | 
| Changes on safety | Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l) | Changes from baseline safety at 90 days | 
| Changes on safety | Gamma glutamyl transferase (U/I) | Changes from baseline safety at 90 days | 
| Changes on safety | Creatinine (mg/dl) | Changes from baseline safety at 90 days | 
| Changes on anthropometric measures | Waist circumference (cm) | Changes from baseline anthropometric measures at 90 days | 
| Changes on anthropometric measures | Body Mass Index (Kg/m2) | Changes from baseline anthropometric measures at 90 days | 
| Changes on body composition | Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g) | Changes from baseline body composition at 90 days | 
| Changes on oxidative stress | Reactive Oxygen Species (CARR U) | Changes from baseline oxidative stress at 90 days | 
| Changes on oxidative stress | Total Antioxidant Capacity (ORAC U) | Changes from baseline oxidative stress at 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Polyglucosamine, Body composition, Inflammation