CompletedNot Applicable

Effects of Bitter Melon on Cardiometabolic Health

United States75 participantsStarted 2023-01-24

Plain-language 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.

Who can participate

Age range18 Years – 74 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Glycated hemoglobin (HbA1c)

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT05540405

SponsorMidwest Center for Metabolic and Cardiovascular Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-24

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