ObesityNCT04916379
Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
A study testing Momordica charantia in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Momordica charantia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 21 Jan 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Momordica charantia, Placebo
- Keywords
- Momordica charantia, Bitter melon, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Momordica charantiaDietary supplement
Also called Bitter melon
Momordica Charantia: 2000 mg per day for 12 weeks
PlaceboOther
Also called Calcined magnesia
Placebo: 2000 mg per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Momordica charantia | Experimental | Two 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks Receives: Dietary Supplement: Momordica charantia |
| Placebo | Placebo comparator | Two 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline body mass index (BMI) at 12 weeks
BMI is calculated at baseline and after 12 weeks with the Quetelet index formula
Measured: 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)
Measured: 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)
Measured: 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
Measured: 12 weeks
Secondary outcomes (12)
Change from baseline fasting plasma glucose (FPG) at 12 weeks
FPG is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Measured: 12 weeks
Change from baseline total cholesterol at 12 weeks
Total cholesterol is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Measured: 12 weeks
Change from baseline triglycerides at 12 weeks
Triglycerides are evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Change from baseline creatinine at 12 weeks
Creatinine is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Measured: 12 weeks
Change from baseline uric acid at 12 weeks
Uric acid is evaluated at baseline and after 12 weeks with enzymatic-colorimetric techniques
Measured: 12 weeks
Change from baseline alanine aminotransferase (ALT) at 12 weeks
ALT is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Measured: 12 weeks
Change from baseline aspartate aminotransferase (AST) at 12 weeks
AST is evaluated at baseline and after 12 weeks with enzymatic/colorimetric techniques
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start21 Jan 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marisol Cortez Navarrete, University of Guadalajara
- Investigators
- Marisol Cortez Navarrete, PhD, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916379
- Sponsor's protocol ID
- MCHOB
- Status last verified
- Aug 2021
- First submitted
- 2 Jun 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35507955
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
- ClinicalTrials.gov ID
- NCT04916379
- Acronym / sponsor ID
- MCHOB
- Conditions
- Obesity
- Keywords
- Momordica charantia, Bitter melon, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Momordica charantia | Experimental | Dietary Supplement: Momordica charantiaTwo 500 mg capsules of Momordica charantia twice daily before breakfast and dinner for 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboTwo 500 mg capsules of calcined magnesia twice daily before breakfast and dinner for 12 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Momordica charantiaAlso: Bitter melonMomordica Charantia: 2000 mg per day for 12 weeks | Dietary supplement | Momordica charantia |
| PlaceboAlso: Calcined magnesiaPlacebo: 2000 mg per day for 12 weeks | Other | Placebo |
Primary outcome
Change from baseline body mass index (BMI) at 12 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 secondary outcomes
Change from baseline fasting plasma glucose (FPG) at 12 weeks
Time frame: 12 weeks
Change from baseline total cholesterol at 12 weeks
Time frame: 12 weeks
Change from baseline triglycerides at 12 weeks
Time frame: 12 weeks
Change from baseline high density lipoprotein cholesterol (HDL-c) at 12 weeks
Time frame: 12 weeks
Change from baseline low density lipoprotein cholesterol (LDL-c) at 12 weeks
Time frame: 12 weeks
Change from baseline very low density lipoprotein (VLDL) at 12 weeks
Time frame: 12 weeks
Change from baseline creatinine at 12 weeks
Time frame: 12 weeks
Change from baseline uric acid at 12 weeks
Time frame: 12 weeks
Change from baseline alanine aminotransferase (ALT) at 12 weeks
Time frame: 12 weeks
Change from baseline aspartate aminotransferase (AST) at 12 weeks
Time frame: 12 weeks
Change from baseline systolic blood pressure at 12 weeks
Time frame: 12 weeks
Change from baseline diastolic blood pressure at 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 35507955Cortez-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marisol Cortez Navarrete, PhD principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Momordica charantia in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline body mass index (BMI) at 12 weeks (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.