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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06193577
• Other study ID #: IBSA-PHAS-0122
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: IBSA Farmaceutici Italia Srl
• Contact: Carmelo Gusmano, MD
• Phone: +393891136444
• Email: carmelo.gusmano[@]yahoo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

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.
• Placebo
The placebo control does not contain active ingredients.

Locations

Country	Name	City	State
Italy	A.O.U. Policlinico "G. Rodolico - San Marco"	Catania

Sponsors (3)

Lead Sponsor	Collaborator
IBSA Farmaceutici Italia Srl	Informapro Srl, Universita degli Studi di Catania

Country where clinical trial is conducted

Italy, 

Outcome

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