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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control formula | Placebo Comparator | Excipients and gum arabic in tablet |
|
| Experimental formula | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyglucosamine L112 | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on anthropometric measures | Body weight (Kg) | Changes from baseline anthropometric measures at 90 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariangela Rondanelli | Fondazione Casemiro Mondino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda di Servizi alla Persona | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Combination Product | excipients and gum arabic |
|
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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |