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

NCT06193577 | Recruiting

• 1 other identifier: IBSA-PHAS-0122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Weight evaluation before and after treatment

  0, 12 weeks

Secondary Outcomes (18)

• Change in weight

  0, 4, 8, 18 weeks

• Change in Body Mass Index

  0, 4, 8, 12, 18 weeks

• Change in glycemia

  0, 4, 8, 12, 18 weeks

• Change in total testosterone levels

  0, 4, 8, 12, 18 weeks

• Change in LH levels

  0, 4, 8, 12, 18 weeks

Study Arms (2)

Phaseolus Vulgaris L. Dry Extract

EXPERIMENTAL

Test

Dietary Supplement: Phaseolus Vulgaris L. Dry Extract

Placebo

PLACEBO COMPARATOR

Control

Dietary Supplement: Placebo

Interventions

Phaseolus Vulgaris L. Dry Extract DIETARY_SUPPLEMENT

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.

Phaseolus Vulgaris L. Dry Extract

Placebo DIETARY_SUPPLEMENT

The placebo control does not contain active ingredients.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead
• Informapro Srl: collaborator
• Universita degli Studi di Catania: collaborator

Study Sites (1)

A.O.U. Policlinico "G. Rodolico - San Marco"

Catania, Catania, 95123, Italy

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aldo Calogero, Prof.

  Università di Catania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmelo Gusmano, MD

CONTACT

+393891136444; carmelo.gusmano@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-centre, prospective, randomized, placebo-controlled, single-blind clinical trial

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 5, 2024
• Study Start: November 8, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IT (1)