Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
- Conditions
- Obesity
- Interventions
- Other: PlaceboDietary Supplement: Momordica charantia
- Registration Number
- NCT04916379
- Lead Sponsor
- University of Guadalajara
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- Diagnosis of obesity type I according to body mass index (IMC: 30.0 - 34.9 kg/m2)
- Body weight without variations above or under 5% in the last three months before entering the study
- Fasting plasma glucose: <126 mg/dL
- Total cholesterol: <240 mg/dL
- Triglycerides: <400 mg/dL
- Women in childbearing years must have a contraceptive method
- Letter of consent and release signed by each patient
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Known uncontrolled renal, hepatic, cardiovascular or thyroid disease
- Physical impossibility for taking pills
- Known hypersensibility to the Momordica charantia or placebo
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks Momordica charantia Momordica charantia Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks
- Primary Outcome Measures
Name Time Method Change from baseline body weight (BW) at 12 weeks 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)
Change from baseline body mass index (BMI) at 12 weeks 12 weeks BMI is calculated at baseline and after 12 weeks with the Quetelet index formula
Change from baseline fat mass at 12 weeks 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)
Change from baseline waist circumference (WC) at 12 weeks 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
- Secondary Outcome Measures
Name Time Method Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks 12 weeks HDL-c is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks 12 weeks LDL-c is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline total cholesterol at 12 weeks 12 weeks Total cholesterol is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline very low density lipoprotein (VLDL) at 12 weeks 12 weeks VLDL is calculated at baseline and after 12 weeks as triglycerides/5
Change from baseline uric acid at 12 weeks 12 weeks Uric acid is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques
Change from baseline alanine aminotransferase (ALT) at 12 weeks 12 weeks ALT is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline aspartate aminotransferase (AST) at 12 weeks 12 weeks AST is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline systolic blood pressure at 12 weeks 12 weeks Systolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer
Change from baseline diastolic blood pressure at 12 weeks 12 weeks Diastolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer
Change from baseline triglycerides at 12 weeks 12 weeks Triglycerides are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline creatinine at 12 weeks 12 weeks Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline fasting plasma glucose (FPG) at 12 weeks 12 weeks FPG is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Trial Locations
- Locations (1)
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico