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Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters

RECRUITINGN/ASponsored by IBSA Farmaceutici Italia Srl
Actively Recruiting
PhaseN/A
SponsorIBSA Farmaceutici Italia Srl
Started2023-11-08
Est. completion2025-06-30
Eligibility
Age18 Years – 60 Years
SexMALE
Healthy vol.Accepted

Summary

Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.

Eligibility

Age: 18 Years – 60 YearsSex: MALEHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions1

Weight Loss

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