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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
View on ClinicalTrials.gov →
NCT06193577
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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Actively Recruiting
PhaseN/A
SponsorIBSA Farmaceutici Italia Srl
Started2023-11-08
Est. completion2025-06-30
Eligibility
Age18 Years – 60 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06193577