Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
- Conditions
- Weight Loss
- Interventions
- Drug: Polyglucosamine L112Other: Placebo
- Registration Number
- NCT04375696
- Lead Sponsor
- Certmedica International GmbH
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Product Polyglucosamine L112 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg Placebo Placebo 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg
- Primary Outcome Measures
Name Time Method Weight Loss 3-month treatment To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
- Secondary Outcome Measures
Name Time Method Triglycerides 3-month treatment To evaluate the effect of PG administration on triglycerides plasma levels
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
Abdominal Circumference 3-month treatment To evaluate the effect of PG administration on the abdominal circumference
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
Trial Locations
- Locations (1)
Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia
🇮🇹Pavia, Lombardia, Italy