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

Launched by IBSA FARMACEUTICI ITALIA SRL · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a natural supplement called Phaseolus vulgaris L. dry extract may help with weight management. The researchers want to see if this extract can affect weight and other health-related factors in men. They are currently recruiting male participants aged 18 to 60 years who have a body mass index (BMI) between 25 and 35, which means they are considered overweight. To join the study, participants must have been stable in their weight for the past three months and agree to stick to their regular diet without using other weight loss products.

Participants in the trial can expect to follow a specific lifestyle during the study, avoiding significant changes and maintaining their usual eating habits. It's important to note that certain health conditions or habits, such as diabetes, smoking more than 10 cigarettes a day, or having a history of eating disorders, could prevent someone from participating. Additionally, individuals who are currently taking other medications for weight loss or have gastrointestinal diseases will not be eligible. If you're interested and meet the criteria, this could be an opportunity to explore a natural approach to weight management while contributing to important research.

Gender

MALE

Eligibility 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