Status:
RECRUITING
Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
Lead Sponsor:
IBSA Farmaceutici Italia Srl
Collaborating Sponsors:
Informapro Srl
Universita degli Studi di Catania
Conditions:
Weight Loss
Eligibility:
MALE
18-60 years
Phase:
NA
Brief Summary
Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.
Detailed Description
Monocentric, prospective, randomized, single-blind clinical trial to evaluate the effects of Phaseolus vulgaris L. dry extract (test) on weight reduction and on metabolic parameters after 12 weeks of ...
Eligibility Criteria
Inclusion
- Male subjects aged between 18 and 60 years
- BMI between 25 and 35 kg/m2
- Habitual consumption of three main meals a day
- Stable body weight during the 3 months prior to enrollment
- Commitment to adhere to the diet and avoid the use of other weight loss products during the study
- Commitment not to change lifestyle significantly for the entire duration of the study.
- Signing of informed consent
Exclusion
- Hypergonadotropic hypogonadism and hypogonadotropic hypogonadism
- Diabetes mellitus
- Smoking \> 10 cigarettes/day
- Alcohol \> 2 alcohol units/day (equal to 24 g of ethanol)
- History of eating disorders during the 12 months prior to enrollment
- Use of any drug or product to treat obesity (e.g. meal replacements)
- Presence of acute or chronic gastrointestinal diseases
- Active use of drugs that could influence the functions: gastrointestinal (e.g. laxatives, etc.), insulin (insulin sensitizers, etc.) and/or testicular (hormones, substances that influece testosterone production
- Known sensitivity to the ingredients of the preparation
- Any other clinical condition judged by the investigator to be incompatible with participation in the trial
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06193577
Start Date
November 8 2023
End Date
June 30 2025
Last Update
January 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
A.O.U. Policlinico "G. Rodolico - San Marco"
Catania, Catania, Italy, 95123