Status:
COMPLETED
Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
Lead Sponsor:
Certmedica International GmbH
Conditions:
Weight Loss
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 admi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04375696
Start Date
April 24 2020
End Date
December 20 2021
Last Update
November 22 2022
Active Locations (1)
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1
Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia
Pavia, Lombardy, Italy, 27100