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

IBSA

Status: Enrolling

Conditions: Weight Loss

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Phaseolus Vulgaris L. Dry Extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06193577

IBSA-PHAS-0122

Details and patient eligibility

About

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

Full description

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).

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Phaseolus Vulgaris L. Dry Extract

Experimental group

Description:

Test

Treatment:

Dietary Supplement: Phaseolus Vulgaris L. Dry Extract

Placebo

Placebo Comparator group

Description:

Control

Treatment:

Dietary Supplement: Placebo