Effects of Phaseolus vulgaris extract on weight and metabolism
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
NA · IBSA Farmaceutici Italia Srl · NCT06193577
This study is testing if an extract from kidney beans can help people lose weight and improve their metabolism over 12 weeks compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | IBSA Farmaceutici Italia Srl (industry) |
| Locations | 1 site (Catania, Catania) |
| Trial ID | NCT06193577 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of Phaseolus vulgaris L. dry extract in promoting weight loss and improving metabolic parameters over a 12-week period. It is a monocentric, prospective, randomized, single-blind study comparing the effects of the extract against a placebo. Participants will be required to maintain their usual diet and lifestyle throughout the study to ensure accurate results.
Who should consider this trial
Good fit: Ideal candidates are male adults aged 18 to 60 with a BMI between 25 and 35 who have stable body weight and consume three meals a day.
Not a fit: Patients with diabetes, significant smoking or alcohol consumption, or a history of eating disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural supplement option for individuals seeking to lose weight and improve their metabolic health.
How similar studies have performed: While there have been studies on natural extracts for weight loss, the specific use of Phaseolus vulgaris L. dry extract in this context is less common, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Catania, Catania
- A.O.U. Policlinico "G. Rodolico - San Marco" — Catania, Catania, Italy (RECRUITING)
Study contacts
- Principal investigator: Aldo Calogero, Prof. — Università di Catania
- Study coordinator: Carmelo Gusmano, MD
- Email: carmelo.gusmano@yahoo.it
- Phone: +393891136444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Weight Loss