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

University of Guadalajara

Status: Unknown

Conditions: Obesity

Treatments: Other: Placebo; Dietary Supplement: Momordica charantia

Study type: Interventional

Funder types: Other

Identifiers

NCT04916379

MCHOB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Momordica charantia

Experimental group

Description:

Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks

Treatment:

Dietary Supplement: Momordica charantia

Placebo

Placebo Comparator group

Description:

Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks

Treatment:

Other: Placebo