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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Momordica charantia; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Momordica charantia; Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks	Dietary supplement: Momordica charantia; Momordica Charantia: 2000 mg per day for 12 weeks; Other Names: Bitter melon
Placebo Comparator: Placebo; Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks	Other: Placebo; Placebo: 2000 mg per day for 12 weeks; Other Names: Calcined magnesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline body mass index (BMI) at 12 weeks	BMI is calculated at baseline and after 12 weeks with the Quetelet index formula	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)	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)	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline fasting plasma glucose (FPG) at 12 weeks	FPG is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Change from baseline total cholesterol at 12 weeks	Total cholesterol is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Change from baseline triglycerides at 12 weeks	Triglycerides are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	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	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	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	12 weeks
Change from baseline creatinine at 12 weeks	Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Change from baseline uric acid at 12 weeks	Uric acid is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques	12 weeks
Change from baseline alanine aminotransferase (ALT) at 12 weeks	ALT is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Change from baseline aspartate aminotransferase (AST) at 12 weeks	AST is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	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	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	12 weeks

Collaborators and Investigators

• Sponsor: University of Guadalajara
• Investigators: Principal Investigator: Marisol Cortez Navarrete, PhD, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Publications and helpful links

General Publications

• Cortez-Navarrete M, Mendez-Del Villar M, Martinez-Abundis E, Lopez-Murillo LD, Escobedo-Gutierrez MJ, Rosales-Rivera LY, Perez-Rubio KG. Effect of Momordica charantia Administration on Anthropometric Measures and Metabolic Profile in Patients with Obesity: A Pilot Clinical Trial. J Med Food. 2022 Jun;25(6):645-651. doi: 10.1089/jmf.2021.0164. Epub 2022 May 4.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Momordica charantia; Bitter melon
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: MCHOB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No