Weight Loss
Conditions
Keywords
Polyglucosamine, Formoline L112, Medical Device
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
Interventions
Polyglucosamine; Ascorbic Acid; Tartaric Acid
OTHERPlacebo
Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide
Sponsors
Certmedica International GmbH
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 3-month treatment | To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol | 3-month treatment | To evaluate the effect of PG administration on total cholesterol plasma levels |
| HOMA | 3-month treatment | To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA |
| Hepatic Enzymes - Renal Functionality | 3-month treatment | To evaluate the effect of PG administration on transaminases and creatinine |
| BMI | 3-month treatment | To evaluate the effect of PG administration on BMI |
| Triglycerides | 3-month treatment | To evaluate the effect of PG administration on triglycerides plasma levels |
| DXA | 3-month treatment | To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry) |
| ROS | 3-month treatment | To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels |
| Antioxidant Serum Capacity | 3-month treatment | To evaluate the effect of PG administration on serum antioxidant capacity |
| Abdominal Circumference | 3-month treatment | To evaluate the effect of PG administration on the abdominal circumference |
Countries
Italy
Outcome results
None listed