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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: Phaseolus Vulgaris L. Dry Extract; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmelo Gusmano, MD; Phone Number: +393891136444; Email: carmelo.gusmano@yahoo.it

Study Locations

• Italy
  • Catania, Italy, 95123
    • Recruiting
    • A.O.U. Policlinico "G. Rodolico - San Marco"
    • Contact: Carmelo Gusmano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Control	Dietary supplement: Placebo; The placebo control does not contain active ingredients.
Experimental: Phaseolus Vulgaris L. Dry Extract; Test	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	Weight evaluation before and after treatment	0, 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IBSA Farmaceutici Italia Srl
• Collaborators: Universita degli Studi di Catania; Informapro Srl
• Investigators: Principal Investigator: Aldo Calogero, Prof., Università di Catania

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: IBSA-PHAS-0122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No