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

Not Applicable

Recruiting

• Conditions: Weight Loss
• Interventions: Dietary Supplement: Phaseolus Vulgaris L. Dry Extract; Dietary Supplement: Placebo

• Registration Number: NCT06193577
• Lead Sponsor: IBSA Farmaceutici Italia Srl

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2023-11-08
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phaseolus Vulgaris L. Dry Extract	Phaseolus Vulgaris L. Dry Extract	Test
Placebo	Placebo	Control

Primary Outcome Measures

Name	Time	Method
Change in weight	0, 12 weeks	Weight evaluation before and after treatment

Secondary Outcome Measures

Name	Time	Method
Change in glycemia	0, 4, 8, 12, 18 weeks	Glycemia evaluation before and after treatment
Change in insulin levels	0, 4, 8, 12, 18 weeks	Insulin levels evaluation before and after treatment
Change in weight	0, 4, 8, 18 weeks	Weight evaluation before and after treatment
Change in carboxylated osteocalcin (cxOCN) levels	0, 4, 8, 12, 18 weeks	Carboxylated osteocalcin levels evaluation before and after treatment
Change in LH levels	0, 4, 8, 12, 18 weeks	Luteinizing hormone (LH) levels evaluation before and after treatment
Change in FSH levels	0, 4, 8, 12, 18 weeks	Follicle-stimulating hormone (FSH) levels evaluation before and after treatment
Change in SHBG levels	0, 4, 8, 12, 18 weeks	Sex Hormone Binding Globulin (SHBG) levels evaluation before and after treatment
Change in uncarboxylated osteocalcin (ucOCN) levels	0, 4, 8, 12, 18 weeks	Uncarboxylated osteocalcin levels evaluation before and after treatment
Change in calculated free testosterone (CFT) concentrations	0, 4, 8, 12, 18 weeks	Calculated free testosterone (CFT) concentrations evaluation before and after treatment
Sperm count	0, 12, 18 weeks	Sperm count before and after treatment
Change in Body Mass Index	0, 4, 8, 12, 18 weeks	BMI evaluation before and after treatment
Change in albumin levels	0, 4, 8, 12, 18 weeks	Albumin levels evaluation before and after treatment
Sperm motility	0, 12, 18 weeks	Sperm motility before and after treatment
Tunel test	0, 12, 18 weeks	Sperm DNA fragmentation evaluation
Change in total testosterone levels	0, 4, 8, 12, 18 weeks	Total testosterone levels evaluation before and after treatment
Change in 17-beta-estradiol levels	0, 4, 8, 12, 18 weeks	17-beta-estradiol levels evaluation before and after treatment
Sperm morphology evaluation	0, 12, 18 weeks	Sperm morphology evaluation before and after treatment
Sperm vitality	0, 12, 18 weeks	Sperm vitality evaluation before and after treatment

Trial Locations

Locations (1)

A.O.U. Policlinico "G. Rodolico - San Marco"; 🇮🇹 Catania, Italy