Effects of Bitter Melon on Cardiometabolic Health

NCT05540405 | Completed

• 1 other identifier: MB-2202
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

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.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c)

  Change in HbA1c

  Baseline to 12 weeks

Secondary Outcomes (12)

• Glycated hemoglobin (HbA1c)

  Baseline to 6 weeks

• Fasting glucose

  Baseline up to 12 weeks

• Fasting insulin

  Baseline up to 12 weeks

• Homeostasis model assessment of insulin sensitivity (HOMA%S)

  Baseline up to 12 weeks

• Homeostasis model assessment of beta-cell function (HOMA%B)

  Baseline up to 12 weeks

Study Arms (3)

Low-dose bitter melon

EXPERIMENTAL

Subject 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 melon

EXPERIMENTAL

Subject will receive 2 Insumate bitter melon capsules/d (300 mg each)

Dietary Supplement: High-dose bitter melon

Placebo

PLACEBO COMPARATOR

Subject will receive 2 placebo capsules/d (300 mg each)

Dietary Supplement: Placebo

Interventions

Low-dose bitter melon DIETARY_SUPPLEMENT

Subject will receive 1 Insumate bitter melon capsule/d (300 mg) and 1 placebo capsule/d (300 mg)

Low-dose bitter melon

High-dose bitter melon DIETARY_SUPPLEMENT

Subject will receive 2 Insumate bitter melon capsules/d (300 mg each)

High-dose bitter melon

Placebo DIETARY_SUPPLEMENT

Subject will receive 2 placebo capsules/d (300 mg each)

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Greenyn Biotechnology: collaborator

Study Sites (3)

Excellence Medical & Research

Miami Gardens, Florida, 33169, United States

Location

Health Awareness

Port Saint Lucie, Florida, 34952, United States

Location

Biofortis, Inc.

Addison, Illinois, 60101, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kevin C Maki, PhD

  MB Clinical Research & Consulting

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: January 24, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)