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

NCT ID: NCT04916379

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Momordica charantia Bitter melon Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Momordica charantia

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

Group Type EXPERIMENTAL

Momordica charantia

Intervention Type DIETARY_SUPPLEMENT

Momordica Charantia: 2000 mg per day for 12 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo: 2000 mg per day for 12 weeks

Interventions

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Momordica charantia

Momordica Charantia: 2000 mg per day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo: 2000 mg per day for 12 weeks

Intervention Type OTHER

Other Intervention Names

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Bitter melon Calcined magnesia

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Guadalajara

OTHER

Sponsor Role lead

Responsible Party

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Marisol Cortez Navarrete

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marisol Cortez Navarrete, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type DERIVED
PMID: 35507955 (View on PubMed)

Other Identifiers

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MCHOB

Identifier Type: -

Identifier Source: org_study_id