Overview

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

Status:
Enrolling by invitation
Trial end date:
2021-09-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Certmedica International GmbH
Criteria
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