An interventional study of Momordica charantia and Placebo in Obesity, sponsored by University of Guadalajara. Status unknown at 1 site in Mexico. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by University of Guadalajara · Not applicable, Interventional, and Treatment
Momordica charantia has shown to exert anti-obesity effects through numerous mechanisms of action described in preclinical studies. Important reductions in body weight and other anthropometric indicators have been reported in clinical trials. However, these beneficial effects of Momordica charantia on obesity have been observed mainly in type 2 diabetes mellitus patients. The purpose of this study is to evaluate the effect of Momordica charantia administration on anthropometric indicators in patients with obesity.
A randomized, double-blind, placebo controlled clinical trial is carried out in 24 patients with obesity according to the body mass index.
Patients are assigned to two different arms: one group receives Momordica charantia, 2 capsules with 500 mg twice daily before breakfast and dinner for 12 weeks or placebo, under the same scheme of treatment.
Body weight, body mass index, waist circumference, body fat percentage and other clinical and laboratory parameters are evaluated.
This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 24 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Guadalajara is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks
Dietary Supplement: Momordica charantia
Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks
Other: Placebo
Momordica Charantia: 2000 mg per day for 12 weeks
Also known as: Bitter melon
Placebo: 2000 mg per day for 12 weeks
Also known as: Calcined magnesia
Change from baseline body mass index (BMI) at 12 weeks
BMI is calculated at baseline and after 12 weeks with the Quetelet index formula
Time frame: 12 weeks
Change from baseline body weight (BW) at 12 weeks
BW is evaluated at baseline and after 12 weeks with an electric bioimpedance digital scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)
Time frame: 12 weeks
Change from baseline fat mass at 12 weeks
Fat mass is measured at baseline and after 12 weeks with an electric bioimpedance digital scale (Model TBF-300 A; Tanita Corporation of America Inc., Arlington Heights, IL)
Time frame: 12 weeks
Change from baseline waist circumference (WC) at 12 weeks
WC is evaluated at baseline and after 12 weeks with a flexible tape in the midpoint between the lowest rib and the iliac crest
Time frame: 12 weeks
Change from baseline fasting plasma glucose (FPG) at 12 weeks
FPG is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline total cholesterol at 12 weeks
Total cholesterol is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline triglycerides at 12 weeks
Triglycerides are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks
HDL-c is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks
LDL-c is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline very low density lipoprotein (VLDL) at 12 weeks
VLDL is calculated at baseline and after 12 weeks as triglycerides/5
Time frame: 12 weeks
Change from baseline creatinine at 12 weeks
Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline uric acid at 12 weeks
Uric acid is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques
Time frame: 12 weeks
Change from baseline alanine aminotransferase (ALT) at 12 weeks
ALT is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline aspartate aminotransferase (AST) at 12 weeks
AST is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time frame: 12 weeks
Change from baseline systolic blood pressure at 12 weeks
Systolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer
Time frame: 12 weeks
Change from baseline diastolic blood pressure at 12 weeks
Diastolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer
Time frame: 12 weeks
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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University of Guadalajara