Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects (POSO)

Certmedica

Status and phase

Completed

Phase 4

Conditions

Weight Loss

Treatments

Other: Placebo

Drug: Polyglucosamine L112

Study type

Interventional

Funder types

Industry

Identifiers

NCT04375696

IT-1501202

Details and patient eligibility

About

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.

Full 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

Enrollment

150 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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