Evaluation of the efficacy of Phaseolus vulgaris L. dry extract on weight modulation.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
The placebo control does not contain active ingredients.
A.O.U. Policlinico "G. Rodolico - San Marco"
Catania, Catania, Italy
RECRUITINGChange in weight
Weight evaluation before and after treatment
Time frame: 0, 12 weeks
Change in weight
Weight evaluation before and after treatment
Time frame: 0, 4, 8, 18 weeks
Change in Body Mass Index
BMI evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in glycemia
Glycemia evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in total testosterone levels
Total testosterone levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in LH levels
Luteinizing hormone (LH) levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in FSH levels
Follicle-stimulating hormone (FSH) levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in SHBG levels
Sex Hormone Binding Globulin (SHBG) levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in 17-beta-estradiol levels
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17-beta-estradiol levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in insulin levels
Insulin levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in albumin levels
Albumin levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in carboxylated osteocalcin (cxOCN) levels
Carboxylated osteocalcin levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in uncarboxylated osteocalcin (ucOCN) levels
Uncarboxylated osteocalcin levels evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Change in calculated free testosterone (CFT) concentrations
Calculated free testosterone (CFT) concentrations evaluation before and after treatment
Time frame: 0, 4, 8, 12, 18 weeks
Sperm count
Sperm count before and after treatment
Time frame: 0, 12, 18 weeks
Sperm motility
Sperm motility before and after treatment
Time frame: 0, 12, 18 weeks
Sperm morphology evaluation
Sperm morphology evaluation before and after treatment
Time frame: 0, 12, 18 weeks
Sperm vitality
Sperm vitality evaluation before and after treatment
Time frame: 0, 12, 18 weeks
Tunel test
Sperm DNA fragmentation evaluation
Time frame: 0, 12, 18 weeks