Actively Recruiting
Study to Evaluate Phaseolus Vulgaris L. Dry Extract for Weight and Metabolic Changes Single-center, Randomized, Placebo-controlled, Single-blind Clinical Trial Testing Effects on Weight and Metabolic Parameters Over 12 Weeks
Led by IBSA Farmaceutici Italia Srl · Updated on 2025-01-08
60
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
Sponsors
I
IBSA Farmaceutici Italia Srl
Lead Sponsor
I
Informapro Srl
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, prospective, randomized, single-blind clinical trial to evaluate the effects of Phaseolus vulgaris L. dry extract on weight loss and metabolic parameters in male adults aged 18 to 60 years. The study aims to compare the efficacy of this dietary supplement against a placebo over 12 weeks. The trial focuses on men with a body mass index (BMI) between 25 and 35 kg/m2 who maintain stable body weight and regular eating habits prior to enrollment. Participants will be randomly assigned to receive either the Phaseolus vulgaris L. dry extract dietary supplement or a placebo, both alongside a balanced diet. The extract is known from previous research to reduce blood sugar levels and food intake, potentially promoting weight loss. The treatment period lasts for 12 weeks, during which participants are expected to adhere to their usual lifestyle and diet without adding other weight loss products. Throughout the study, participants will be monitored for changes in weight at the start and after 12 weeks of supplementation. Researchers will assess metabolic parameters and ensure safety by tracking adherence to diet and supplement use. The study includes regular evaluations and requires participants' commitment to maintain consistent lifestyle habits for the entire duration to ensure reliable results.
CONDITIONS
Official Title
Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
Who Can Participate
Eligibility Criteria
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
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
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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
Research Team
C
Carmelo Gusmano, MD
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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