Obesity
Conditions
Keywords
Obesity, Polyglucosamine, Body composition, Inflammation
Brief summary
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
Interventions
DIETARY_SUPPLEMENTPolyglucosamine 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
COMBINATION_PRODUCTPlacebo
excipients and gum arabic
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on anthropometric measures | Changes from baseline anthropometric measures at 90 days | Body weight (Kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on insulin resistance | Changes from baseline insulin resistance at 90 days | Homeostasis Model Assessment (pt) for evaluate insulin resistance il \> 2,4 |
| Changes on Carbohydrate profile | Changes from baseline Carbohydrate profile at 90 days | Glycemia (mg/dl) |
| Changes on safety | Changes from baseline safety at 90 days | Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l) |
| Changes on lipid profile | Changes from baseline lipid profile at 90 days | Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl) |
| Changes on body composition | Changes from baseline body composition at 90 days | Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g) |
| Changes on oxidative stress | Changes from baseline oxidative stress at 90 days | Reactive Oxygen Species (CARR U) |
| Changes on anthropometric measures | Changes from baseline anthropometric measures at 90 days | Waist circumference (cm) |
Countries
Italy
Outcome results
None listed