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

NCT04916379 | Unknown

• 1 other identifier: MCHOB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Momordica charantia; Bitter melon; Obesity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Change from baseline fasting plasma glucose (FPG) at 12 weeks

  12 weeks

• Change from baseline total cholesterol at 12 weeks

  12 weeks

• Change from baseline triglycerides at 12 weeks

  12 weeks

• Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks

  12 weeks

• Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks

  12 weeks

Study Arms (2)

Momordica charantia

EXPERIMENTAL

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

Dietary Supplement: Momordica charantia

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Momordica charantia DIETARY_SUPPLEMENT

Momordica Charantia: 2000 mg per day for 12 weeks

Also known as: Bitter melon

Momordica charantia

Placebo OTHER

Placebo: 2000 mg per day for 12 weeks

Also known as: Calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (1)

• 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.

  PMID: 35507955 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

bitter melon extract

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marisol Cortez Navarrete, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 7, 2021
• Study Start: January 21, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

ME (1)