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

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

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 supplementation. The efficacy on weight reduction will be evaluated in comparison with the placebo group (control).

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