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

NCT ID: NCT06193577

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-centre, prospective, randomized, placebo-controlled, single-blind clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Phaseolus Vulgaris L. Dry Extract

Test

Group Type EXPERIMENTAL

Phaseolus Vulgaris L. Dry Extract

Intervention Type 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.

Placebo

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo control does not contain active ingredients.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo control does not contain active ingredients.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Informapro Srl

OTHER

Sponsor Role collaborator

Universita degli Studi di Catania

OTHER

Sponsor Role collaborator

IBSA Farmaceutici Italia Srl

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aldo Calogero, Prof.

Role: PRINCIPAL_INVESTIGATOR

Università di Catania

Locations

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

Catania, Catania, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carmelo Gusmano, MD

Role: CONTACT

+393891136444

Facility Contacts

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Carmelo Gusmano, MD

Role: primary

Other Identifiers

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IBSA-PHAS-0122

Identifier Type: -

Identifier Source: org_study_id

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