Clinical trial NCT06193577: Effect of Phaseolus Vulgaris L. Dry Extract on the Modulation of Weight and Metabolic Parameters
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Lead sponsor: IBSA Farmaceutici Italia Srl
Sponsor class: INDUSTRY
Collaborators: name: Informapro Srl
name: Universita degli Studi di Catania
First posted: 2024-01-05
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre, prospective, randomized, placebo-controlled, single-blind clinical trial
Primary purpose: TREATMENT

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

Detailed description: 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).

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

Primary outcomes:
measure: Change in weight
timeFrame: 0, 12 weeks
Secondary outcomes:
measure: Change in weight
timeFrame: 0, 4, 8, 18 weeks
measure: Change in Body Mass Index
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in glycemia
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in total testosterone levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in LH levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in FSH levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in SHBG levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in 17-beta-estradiol levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in insulin levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in albumin levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in carboxylated osteocalcin (cxOCN) levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in uncarboxylated osteocalcin (ucOCN) levels
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Change in calculated free testosterone (CFT) concentrations
timeFrame: 0, 4, 8, 12, 18 weeks
measure: Sperm count
timeFrame: 0, 12, 18 weeks
measure: Sperm motility
timeFrame: 0, 12, 18 weeks
measure: Sperm morphology evaluation
timeFrame: 0, 12, 18 weeks
measure: Sperm vitality
timeFrame: 0, 12, 18 weeks
measure: Tunel test
timeFrame: 0, 12, 18 weeks
Other outcomes:
Locations:
city: Catania
country: Italy
facility: A.O.U. Policlinico "G. Rodolico - San Marco"
Study officials:
affiliation: Università di Catania
name: Aldo Calogero, Prof.
role: PRINCIPAL_INVESTIGATOR
References: