Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
Single-centre, Prospective, Randomized, Placebo-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of a Food Supplement Based on Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
IBSA Farmaceutici Italia Srl
60 participants
Nov 8, 2023
INTERVENTIONAL
Conditions
Summary
Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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
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Interventions
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.
The placebo control does not contain active ingredients.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06193577