Effects of Bitter Melon on Cardiometabolic Health

May 30, 2023 updated by: Midwest Center for Metabolic and Cardiovascular Research

A Randomized, Double-blind, Controlled, Parallel-arm Trial to Assess the Effects of a Bitter Melon Product at Two Doses vs. Control on Indicators of Cardiometabolic Health in Men and Women With Prediabetes

The objectives of this study are to assess the effects of a bitter melon product at two doses, compared to control, on indicators of cardiometabolic health among men and women with prediabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Gardens, Florida, United States, 33169
        • Excellence Medical & Research
      • Port Saint Lucie, Florida, United States, 34952
        • Health Awareness
    • Illinois
      • Addison, Illinois, United States, 60101
        • Biofortis, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female 18 to 74 years of age, inclusive.
  2. Subject has BMI 25.00 to 39.99 kg/m2, inclusive.
  3. Subject has prediabetes defined as fasting capillary glucose 100 to 125 mg/dL, inclusive, and/or HbA1c 5.7% to 6.4%, inclusive, at screening.
  4. Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
  5. Subject is willing to abstain from consumption of bitter melon (other than the study products) throughout the study.
  6. Subject is willing and able to undergo the scheduled study procedures.
  7. Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  1. Subject has consumed a bitter melon food or product within 8 weeks prior to the screening visit (week -1) (washout permitted).
  2. Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
  3. Subject has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
  4. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
  5. Subject has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
  6. Subject has had a weight change of +/-4.5 kg (10 lbs) in the previous 3 months.
  7. Subject has extreme dietary habits (e.g., Atkins, vegan, very low carbohydrate diet).
  8. Subject has a history of bariatric surgery, is currently taking a weight loss drug, or is actively attempting to lose or gain body weight.
  9. Subject has taken a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor agent within 12 weeks prior to screening.
  10. Subject has unstable use (defined as initiation or change in dose) of the following lipid-altering medications within 4 weeks prior to screening: bile acid sequestrants, fibrates, niacin (drug form), statins, ezetimibe, bempedoic acid, or omega-3-ethyl ester drugs.
  11. Subject has taken any hypoglycemic medications within 4 weeks prior to screening including: insulin, sodium-glucose cotransporter-2 (SGLT2)-inhibitors, alpha-glucosidase inhibitors, biguanides, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sulfonylureas, glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) modulators.
  12. Subject has unstable use (defined as initiation or change in dose) of anti-hypertensive medications within 4 weeks prior to screening.
  13. Subject has used systemic corticosteroids within 4 weeks prior to screening.
  14. Subject has taken dietary supplements meant to regulate carbohydrate or lipid metabolism or body weight, within 4 weeks of screening, including, but not limited to, chromium picolinate, ginseng, starch blockers, omega-3 fatty acid supplements (e.g., flaxseed, fish or algal oils), red rice yeast supplements, garlic supplements, soy isoflavone supplements, niacin or its analogues at doses >400 mg/day, plant sterol or stanols, and/or irregular or inconsistent use of Metamucil® or other viscous fiber-containing supplements (consistent, daily use up to 1 teaspoon of a viscous-fiber supplement is acceptable).
  15. Subject has signs or symptoms of an active infection of clinical significance or has taken antibiotics within 5 days prior to any visit (washout is permitted for re-scheduling of the clinic visit).
  16. Subject has an allergy, sensitivity or intolerance to any components of the study products.
  17. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  18. Subject has been exposed to any non-registered drug product within 30 days prior to screening.
  19. Subject has a current or recent history (within 12 months prior to screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
  20. Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-dose bitter melon
Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg)
Dietary supplement: Low-dose bitter melon
Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg)
Experimental: High-dose bitter melon
Subject will receive 2 Insumate bitter melon capsules/d (300 mg each)
Dietary supplement: High-dose bitter melon
Subject will receive 2 Insumate bitter melon capsules/d (300 mg each)
Placebo Comparator: Placebo
Subject will receive 2 placebo capsules/d (300 mg each)
Dietary supplement: Placebo
Subject will receive 2 placebo capsules/d (300 mg each)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: Baseline to 12 weeks
Change in HbA1c
Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: Baseline to 6 weeks
Change in HbA1c
Baseline to 6 weeks
Fasting glucose
Time Frame: Baseline up to 12 weeks
Change in fasting glucose
Baseline up to 12 weeks
Fasting insulin
Time Frame: Baseline up to 12 weeks
Change in fasting insulin
Baseline up to 12 weeks
Homeostasis model assessment of insulin sensitivity (HOMA%S)
Time Frame: Baseline up to 12 weeks
Change in HOMA%S
Baseline up to 12 weeks
Homeostasis model assessment of beta-cell function (HOMA%B)
Time Frame: Baseline up to 12 weeks
Change in HOMA%B
Baseline up to 12 weeks
Total cholesterol
Time Frame: Baseline up to 12 weeks
Change in total cholesterol
Baseline up to 12 weeks
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline up to 12 weeks
Change in LDL-C
Baseline up to 12 weeks
High-density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline up to 12 weeks
Change in HDL-C
Baseline up to 12 weeks
Non-HDL-C
Time Frame: Baseline up to 12 weeks
Change in non-HDL-C
Baseline up to 12 weeks
Fasting triglycerides
Time Frame: Baseline up to 12 weeks
Change in triglycerides
Baseline up to 12 weeks
Body fat
Time Frame: Baseline up to 12 weeks
Change in body fat
Baseline up to 12 weeks
Skeletal muscle mass
Time Frame: Baseline up to 12 weeks
Change in skeletal muscle mass
Baseline up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Midwest Center for Metabolic and Cardiovascular Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Greenyn Biotechnology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kevin C Maki, PhD, MB Clinical Research & Consulting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MB-2202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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