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