Clinical trial NCT05540405: Effects of Bitter Melon on Cardiometabolic Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Midwest Center for Metabolic and Cardiovascular Research
Sponsor class: OTHER
Collaborators: name: Greenyn Biotechnology
First posted: 2022-09-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline to 6 weeks
measure: Fasting glucose
timeFrame: Baseline up to 12 weeks
measure: Fasting insulin
timeFrame: Baseline up to 12 weeks
measure: Homeostasis model assessment of insulin sensitivity (HOMA%S)
timeFrame: Baseline up to 12 weeks
measure: Homeostasis model assessment of beta-cell function (HOMA%B)
timeFrame: Baseline up to 12 weeks
measure: Total cholesterol
timeFrame: Baseline up to 12 weeks
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline up to 12 weeks
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: Baseline up to 12 weeks
measure: Non-HDL-C
timeFrame: Baseline up to 12 weeks
measure: Fasting triglycerides
timeFrame: Baseline up to 12 weeks
measure: Body fat
timeFrame: Baseline up to 12 weeks
measure: Skeletal muscle mass
timeFrame: Baseline up to 12 weeks
Other outcomes:
Locations:
city: Miami Gardens
country: United States
facility: Excellence Medical & Research
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness
state: Florida
city: Addison
country: United States
facility: Biofortis, Inc.
state: Illinois
Study officials:
affiliation: MB Clinical Research & Consulting
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References: