Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
MALE
NCT06193577

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

Led by IBSA Farmaceutici Italia Srl · Updated on 2025-01-08

60

Participants Needed

1

Research Sites

85 weeks

Total Duration

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Sponsors

I

IBSA Farmaceutici Italia Srl

Lead Sponsor

I

Informapro Srl

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Catania, Catania, Italy, 95123

Actively Recruiting

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Research Team

C

Carmelo Gusmano, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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