Assessing the Impact of a Plant-Based Diet for Diabetes Prevention (NCT06571279) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
United States9 participantsStarted 2024-10-14
Plain-language summary
The primary purpose of this study is to determine the sex-specific metabolic and molecular response, among adults with prediabetes, when moving from a Western Diet to plant-based diet.
Who can participate
Age range
30 Years – 55 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:
* Body mass index greater than or equal to 27
* High waist circumference (women greater than or equal to 35"; men greater than or equal to 40")
* Prediabetes (based on fasting glucose 100-125 mg/dL, HbA1c 5.7-6.4, or 2-hr post-oral glucose tolerance test glucose screen between 140-199mg/dL)
* Physical activity below national guidelines
* Aged 30-55 (premenopausal for women)
* Following a Western diet
Exclusion Criteria:
* Diabetes diagnosis
* Take medications that may affect insulin sensitivity
* More than 5% weight change within 6 months of screening
* History of bariatric surgery
* Report any dietary supplement, medication, or medical condition known to significantly affect weight or metabolism
* Take hormone replacement therapy
* Consume 3 or more servings of combined fruit and vegetables daily and/or 3 or more servings of whole grains daily
* Any food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0 or allergy to lidocaine
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
Insulin sensitivity (glucose infusion rate)
Timeframe: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.
2
Skeletal muscle d-chiroinositol content
Timeframe: The first measure is taken immediately after the run-in and the final measure will be taken immediately after the completion of the plant-based diet intervention five weeks later.