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Recruiting Not applicable

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

NCT06193577 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-11-08
Last updated
2025-01-08

Condition(s) studied

Weight Loss

Investigational drug(s) / intervention(s)

Phaseolus Vulgaris L. Dry ExtractPlacebo

Phaseolus Vulgaris L. Dry Extract: Extracts of Phaseolus vulgaris (beans) in association with a balanced diet are known to reduce glycaemia and food intake in rodents and humans thus promoting weight loss.

Placebo: The placebo control does not contain active ingredients.

Study summary

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

Eligibility

Sex
MALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in weight — 0, 12 weeks
    Weight evaluation before and after treatment

Trial sites (1)

FacilityCityRegionStatus
A.O.U. Policlinico "G. Rodolico - San Marco" Catania Catania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06193577 on ClinicalTrials.gov ↗ ← All trials in Italy