Weight Loss
Conditions
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).
Interventions
DIETARY_SUPPLEMENTPhaseolus 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.
DIETARY_SUPPLEMENTPlacebo
The placebo control does not contain active ingredients.
Sponsors
IBSA Farmaceutici Italia Srl
Informapro Srl
Universita degli Studi di Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Single-centre, prospective, randomized, placebo-controlled, single-blind clinical trial
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | 0, 12 weeks | Weight evaluation before and after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm motility | 0, 12, 18 weeks | Sperm motility before and after treatment |
| Sperm morphology evaluation | 0, 12, 18 weeks | Sperm morphology evaluation before and after treatment |
| Sperm vitality | 0, 12, 18 weeks | Sperm vitality evaluation before and after treatment |
| Tunel test | 0, 12, 18 weeks | Sperm DNA fragmentation evaluation |
| Change in weight | 0, 4, 8, 18 weeks | Weight evaluation before and after treatment |
| Change in Body Mass Index | 0, 4, 8, 12, 18 weeks | BMI evaluation before and after treatment |
| Change in glycemia | 0, 4, 8, 12, 18 weeks | Glycemia evaluation before and after treatment |
| Change in total testosterone levels | 0, 4, 8, 12, 18 weeks | Total testosterone levels evaluation before and after treatment |
| Sperm count | 0, 12, 18 weeks | Sperm count before and after treatment |
| Change in FSH levels | 0, 4, 8, 12, 18 weeks | Follicle-stimulating hormone (FSH) levels evaluation before and after treatment |
| Change in SHBG levels | 0, 4, 8, 12, 18 weeks | Sex Hormone Binding Globulin (SHBG) levels evaluation before and after treatment |
| Change in 17-beta-estradiol levels | 0, 4, 8, 12, 18 weeks | 17-beta-estradiol levels evaluation before and after treatment |
| Change in insulin levels | 0, 4, 8, 12, 18 weeks | Insulin levels evaluation before and after treatment |
| Change in albumin levels | 0, 4, 8, 12, 18 weeks | Albumin levels evaluation before and after treatment |
| Change in carboxylated osteocalcin (cxOCN) levels | 0, 4, 8, 12, 18 weeks | Carboxylated osteocalcin levels evaluation before and after treatment |
| Change in uncarboxylated osteocalcin (ucOCN) levels | 0, 4, 8, 12, 18 weeks | Uncarboxylated osteocalcin levels evaluation before and after treatment |
| Change in calculated free testosterone (CFT) concentrations | 0, 4, 8, 12, 18 weeks | Calculated free testosterone (CFT) concentrations evaluation before and after treatment |
| Change in LH levels | 0, 4, 8, 12, 18 weeks | Luteinizing hormone (LH) levels evaluation before and after treatment |
Countries
Italy
Contacts
Primary ContactCarmelo Gusmano, MD
Outcome results
None listed