Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity

University of Guadalajara24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

Momordica charantiaDIETARY_SUPPLEMENT

Momordica Charantia: 2000 mg per day for 12 weeks

PlaceboOTHER

Placebo: 2000 mg per day for 12 weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.