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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Momordica charantia
Placebo
Sponsored by
University of Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Momordica charantia, Bitter melon, Obesity

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Momordica charantia

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline body mass index (BMI) at 12 weeks
BMI is calculated at baseline and after 12 weeks with the Quetelet index formula
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)
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)
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

Secondary Outcome Measures

Change from baseline fasting plasma glucose (FPG) at 12 weeks
FPG is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline total cholesterol at 12 weeks
Total cholesterol is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline triglycerides at 12 weeks
Triglycerides are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
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
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
Change from baseline very low density lipoprotein (VLDL) at 12 weeks
VLDL is calculated at baseline and after 12 weeks as triglycerides/5
Change from baseline creatinine at 12 weeks
Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline uric acid at 12 weeks
Uric acid is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques
Change from baseline alanine aminotransferase (ALT) at 12 weeks
ALT is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline aspartate aminotransferase (AST) at 12 weeks
AST is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Change from baseline systolic blood pressure at 12 weeks
Systolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer
Change from baseline diastolic blood pressure at 12 weeks
Diastolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer

Full Information

First Posted
June 2, 2021
Last Updated
August 29, 2021
Sponsor
University of Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT04916379
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Momordica charantia, Bitter melon, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Momordica charantia
Arm Type
Experimental
Arm Description
Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Momordica charantia
Other Intervention Name(s)
Bitter melon
Intervention Description
Momordica Charantia: 2000 mg per day for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Calcined magnesia
Intervention Description
Placebo: 2000 mg per day for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline body mass index (BMI) at 12 weeks
Description
BMI is calculated at baseline and after 12 weeks with the Quetelet index formula
Time Frame
12 weeks
Title
Change from baseline body weight (BW) at 12 weeks
Description
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)
Time Frame
12 weeks
Title
Change from baseline fat mass at 12 weeks
Description
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)
Time Frame
12 weeks
Title
Change from baseline waist circumference (WC) at 12 weeks
Description
WC is evaluated at baseline and after 12 weeks with a flexible tape in the midpoint between the lowest rib and the iliac crest
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline fasting plasma glucose (FPG) at 12 weeks
Description
FPG is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline total cholesterol at 12 weeks
Description
Total cholesterol is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline triglycerides at 12 weeks
Description
Triglycerides are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks
Description
HDL-c is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks
Description
LDL-c is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline very low density lipoprotein (VLDL) at 12 weeks
Description
VLDL is calculated at baseline and after 12 weeks as triglycerides/5
Time Frame
12 weeks
Title
Change from baseline creatinine at 12 weeks
Description
Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline uric acid at 12 weeks
Description
Uric acid is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline alanine aminotransferase (ALT) at 12 weeks
Description
ALT is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline aspartate aminotransferase (AST) at 12 weeks
Description
AST is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Time Frame
12 weeks
Title
Change from baseline systolic blood pressure at 12 weeks
Description
Systolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer
Time Frame
12 weeks
Title
Change from baseline diastolic blood pressure at 12 weeks
Description
Diastolic blood pressure is measured at baseline and after 12 weeks with a digital sphygmomanometer
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisol Cortez Navarrete, PhD
Organizational Affiliation
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
35507955
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.
Results Reference
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Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity

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