Clinical trial NCT04916379: Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
Official title: Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Momordica charantia
Bitter melon
Obesity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline body mass index (BMI) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline body weight (BW) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline fat mass at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline waist circumference (WC) at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline fasting plasma glucose (FPG) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline total cholesterol at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline triglycerides at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline very low density lipoprotein (VLDL) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline creatinine at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline uric acid at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline alanine aminotransferase (ALT) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline aspartate aminotransferase (AST) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline systolic blood pressure at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline diastolic blood pressure at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
name: Marisol Cortez Navarrete, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.