Effects of Bitter Melon on Cardiometabolic Health (NCT05540405) | Clinical Trial Compass
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 range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glycated hemoglobin (HbA1c)
Timeframe: Baseline to 12 weeks
Trial details
NCT IDNCT05540405
SponsorMidwest Center for Metabolic and Cardiovascular Research
. 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.