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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momordica charantia | Experimental | Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks |
|
| Placebo | Placebo Comparator | Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momordica charantia | Dietary Supplement | Momordica Charantia: 2000 mg per day for 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marisol Cortez Navarrete, PhD | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35507955 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000713349 | bitter melon extract |
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| Placebo | Other | Placebo: 2000 mg per day for 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |