Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Guadalajara
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change from baseline body weight (BW) at 12 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Placebo
Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks
Intervention: Placebo (Other)
Momordica charantia
Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks
Intervention: Momordica charantia (Dietary Supplement)
Outcomes
Primary Outcomes
Change from baseline body weight (BW) at 12 weeks
Time Frame: 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
Time Frame: 12 weeks
BMI is calculated at baseline and after 12 weeks with the Quetelet index formula
Change from baseline fat mass at 12 weeks
Time Frame: 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
Time Frame: 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 Outcomes
- Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks(12 weeks)
- Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks(12 weeks)
- Change from baseline total cholesterol at 12 weeks(12 weeks)
- Change from baseline very low density lipoprotein (VLDL) at 12 weeks(12 weeks)
- Change from baseline uric acid at 12 weeks(12 weeks)
- Change from baseline alanine aminotransferase (ALT) at 12 weeks(12 weeks)
- Change from baseline aspartate aminotransferase (AST) at 12 weeks(12 weeks)
- Change from baseline systolic blood pressure at 12 weeks(12 weeks)
- Change from baseline diastolic blood pressure at 12 weeks(12 weeks)
- Change from baseline fasting plasma glucose (FPG) at 12 weeks(12 weeks)
- Change from baseline triglycerides at 12 weeks(12 weeks)
- Change from baseline creatinine at 12 weeks(12 weeks)
Investigators
Marisol Cortez Navarrete
Principal investigator
University of Guadalajara