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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Momordica charantia
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Momordica charantia<br>Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks | Dietary Supplement: Momordica charantia<br>* Momordica Charantia: 2000 mg per day for 12 weeks<br>* Other names: Bitter melon;|
| Placebo Comparator: Placebo<br>Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks | Other: Placebo<br>* Placebo: 2000 mg per day for 12 weeks<br>* Other names: Calcined magnesia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Momordica charantia, Bitter melon, Obesity