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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04916379
• Other study ID #: MCHOB
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2021
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Momordica charantia
Momordica Charantia: 2000 mg per day for 12 weeks

Other:
• Placebo
Placebo: 2000 mg per day for 12 weeks

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change from baseline total cholesterol at 12 weeks	Total cholesterol is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Secondary	Change from baseline triglycerides at 12 weeks	Triglycerides are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline creatinine at 12 weeks	Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Secondary	Change from baseline uric acid at 12 weeks	Uric acid is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques	12 weeks
Secondary	Change from baseline alanine aminotransferase (ALT) at 12 weeks	ALT is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Secondary	Change from baseline aspartate aminotransferase (AST) at 12 weeks	AST is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques	12 weeks
Secondary	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
Secondary	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