Effects of Bitter Melon on Cardiometabolic Health

PreDiabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540405
• Other study ID #: MB-2202
• Status: Completed
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: Midwest Center for Metabolic and Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Low-dose bitter melon
Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg)
• High-dose bitter melon
Subject will receive 2 Insumate bitter melon capsules/d (300 mg each)
• Placebo
Subject will receive 2 placebo capsules/d (300 mg each)

Locations

Country	Name	City	State
United States	Biofortis, Inc.	Addison	Illinois
United States	Excellence Medical & Research	Miami Gardens	Florida
United States	Health Awareness	Port Saint Lucie	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Midwest Center for Metabolic and Cardiovascular Research	Greenyn Biotechnology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1c)	Change in HbA1c	Baseline to 12 weeks
Secondary	Glycated hemoglobin (HbA1c)	Change in HbA1c	Baseline to 6 weeks
Secondary	Fasting glucose	Change in fasting glucose	Baseline up to 12 weeks
Secondary	Fasting insulin	Change in fasting insulin	Baseline up to 12 weeks
Secondary	Homeostasis model assessment of insulin sensitivity (HOMA%S)	Change in HOMA%S	Baseline up to 12 weeks
Secondary	Homeostasis model assessment of beta-cell function (HOMA%B)	Change in HOMA%B	Baseline up to 12 weeks
Secondary	Total cholesterol	Change in total cholesterol	Baseline up to 12 weeks
Secondary	Low-density lipoprotein cholesterol (LDL-C)	Change in LDL-C	Baseline up to 12 weeks
Secondary	High-density lipoprotein cholesterol (HDL-C)	Change in HDL-C	Baseline up to 12 weeks
Secondary	Non-HDL-C	Change in non-HDL-C	Baseline up to 12 weeks
Secondary	Fasting triglycerides	Change in triglycerides	Baseline up to 12 weeks
Secondary	Body fat	Change in body fat	Baseline up to 12 weeks
Secondary	Skeletal muscle mass	Change in skeletal muscle mass	Baseline up to 12 weeks