PreDiabetesNCT05540405
Effects of Bitter Melon on Cardiometabolic Health
A study testing Low-dose bitter melon and High-dose bitter melon in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Low-dose bitter melon and High-dose bitter melon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jan 2023to 24 May 2023
- 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 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 to 74 years of age, inclusive.
- Subject has BMI 25.00 to 39.99 kg/m2, inclusive.
- 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.
- Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- Subject is willing to abstain from consumption of bitter melon (other than the study products) throughout the study.
- Subject is willing and able to undergo the scheduled study procedures.
- 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.
Who cannot join
- Subject has consumed a bitter melon food or product within 8 weeks prior to the screening visit (week -1) (washout permitted).
- Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- Subject has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
- Subject has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
- Subject has had a weight change of +/-4.5 kg (10 lbs) in the previous 3 months.
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- Subject has extreme dietary habits (e.g., Atkins, vegan, very low carbohydrate diet).
- Subject has a history of bariatric surgery, is currently taking a weight loss drug, or is actively attempting to lose or gain body weight.
- Subject has taken a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor agent within 12 weeks prior to screening.
- 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.
- 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.
- Subject has unstable use (defined as initiation or change in dose) of anti-hypertensive medications within 4 weeks prior to screening.
- Subject has used systemic corticosteroids within 4 weeks prior to screening.
- 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).
- 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).
- Subject has an allergy, sensitivity or intolerance to any components of the study products.
- 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.
- Subject has been exposed to any non-registered drug product within 30 days prior to screening.
- 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).
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Biofortis, Inc.
Addison, Illinois, 60101
Excellence Medical & Research
Miami Gardens, Florida, 33169
Health Awareness
Port Saint Lucie, Florida, 34952
About this study
Official title: 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.
- Conditions
- PreDiabetes
- Being tested
- Low-dose bitter melon, High-dose bitter melon, Placebo
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose bitter melonDietary supplement
Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg)
High-dose bitter melonDietary supplement
Subject will receive 2 Insumate bitter melon capsules/d (300 mg each)
PlaceboDietary supplement
Subject will receive 2 placebo capsules/d (300 mg each)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose bitter melon | Experimental | Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg) Receives: Dietary Supplement: Low-dose bitter melon |
| High-dose bitter melon | Experimental | Subject will receive 2 Insumate bitter melon capsules/d (300 mg each) Receives: Dietary Supplement: High-dose bitter melon |
| Placebo | Placebo comparator | Subject will receive 2 placebo capsules/d (300 mg each) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
Change in HbA1c
Measured: Baseline to 12 weeks
Secondary outcomes (12)
Glycated hemoglobin (HbA1c)
Change in HbA1c
Measured: Baseline to 6 weeks
Fasting glucose
Change in fasting glucose
Measured: Baseline up to 12 weeks
Fasting insulin
Change in fasting insulin
Measured: Baseline up to 12 weeks
Homeostasis model assessment of insulin sensitivity (HOMA%S)
Change in HOMA%S
Measured: Baseline up to 12 weeks
Homeostasis model assessment of beta-cell function (HOMA%B)
Change in HOMA%B
Measured: Baseline up to 12 weeks
Total cholesterol
Change in total cholesterol
Measured: Baseline up to 12 weeks
Low-density lipoprotein cholesterol (LDL-C)
Change in LDL-C
Measured: Baseline up to 12 weeks
High-density lipoprotein cholesterol (HDL-C)
Change in HDL-C
Measured: Baseline up to 12 weeks
Non-HDL-C
Change in non-HDL-C
Measured: Baseline up to 12 weeks
Fasting triglycerides
Change in triglycerides
Measured: Baseline up to 12 weeks
Body fat
Change in body fat
Measured: Baseline up to 12 weeks
Skeletal muscle mass
Change in skeletal muscle mass
Measured: Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start24 Jan 2023
- Primary completion24 May 2023
- Study completion24 May 2023
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 PreDiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Greenyn Biotechnology
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, MB Clinical Research & Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540405
- Sponsor's protocol ID
- MB-2202
- Status last verified
- May 2023
- First submitted
- 9 Sep 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guarneiri LL, Wilcox ML, Kuan CM, Maki KC. Investigation of the Influence of a Bitter Melon Product on Indicators of Cardiometabolic Health in Adults with Prediabetes. J Am Nutr Assoc. 2025 May-Jun;44(4):306-314. doi: 10.1080/27697061.2024.2428301. Epub 2024 Nov 13.
PubMed 39536276
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05540405
- Acronym / sponsor ID
- MB-2202
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Greenyn Biotechnology
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 14 Sep 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose bitter melon | Experimental | Dietary Supplement: Low-dose bitter melonSubject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg) |
| High-dose bitter melon | Experimental | Dietary Supplement: High-dose bitter melonSubject will receive 2 Insumate bitter melon capsules/d (300 mg each) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubject will receive 2 placebo capsules/d (300 mg each) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 18 to 74 years of age, inclusive.
- Subject has BMI 25.00 to 39.99 kg/m2, inclusive.
- 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.
- Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
- Subject is willing to abstain from consumption of bitter melon (other than the study products) throughout the study.
Key exclusion criteria (20 listed)
- Subject has consumed a bitter melon food or product within 8 weeks prior to the screening visit (week -1) (washout permitted).
- Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- Subject has a clinically significant medical condition that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
- Subject has a history of cancer in the prior 5 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
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 |
|---|---|---|
| Low-dose bitter melonSubject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg) | Dietary supplement | Low-dose bitter melon |
| High-dose bitter melonSubject will receive 2 Insumate bitter melon capsules/d (300 mg each) | Dietary supplement | High-dose bitter melon |
| PlaceboSubject will receive 2 placebo capsules/d (300 mg each) | Dietary supplement | Placebo |
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: Baseline to 12 weeks
Change in HbA1c
12 secondary outcomes
Glycated hemoglobin (HbA1c)
Time frame: Baseline to 6 weeks
Fasting glucose
Time frame: Baseline up to 12 weeks
Fasting insulin
Time frame: Baseline up to 12 weeks
Homeostasis model assessment of insulin sensitivity (HOMA%S)
Time frame: Baseline up to 12 weeks
Homeostasis model assessment of beta-cell function (HOMA%B)
Time frame: Baseline up to 12 weeks
Total cholesterol
Time frame: Baseline up to 12 weeks
Low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline up to 12 weeks
High-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline up to 12 weeks
Non-HDL-C
Time frame: Baseline up to 12 weeks
Fasting triglycerides
Time frame: Baseline up to 12 weeks
Body fat
Time frame: Baseline up to 12 weeks
Skeletal muscle mass
Time frame: Baseline up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 39536276Guarneiri LL, Wilcox ML, Kuan CM, Maki KC. Investigation of the Influence of a Bitter Melon Product on Indicators of Cardiometabolic Health in Adults with Prediabetes. J Am Nutr Assoc. 2025 May-Jun;44(4):306-314. doi: 10.1080/27697061.2024.2428301. Epub 2024 Nov 13.
- Individual participant dataSharing planned: No
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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.
Kevin C Maki, PhD study director
MB Clinical Research & Consulting
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose bitter melon and High-dose bitter melon in people with PreDiabetes, run by Midwest Center for Metabolic and Cardiovascular Research at 3 sites in United States.
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 20 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: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycated hemoglobin (HbA1c) (time frame: Baseline to 12 weeks). 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 NCT05540405, 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 May 2023.