Impact of a Plant-Based Diet on Diabetes Prevention
Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
This study is testing whether switching to a plant-based diet can help adults with prediabetes improve their insulin sensitivity and overall metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06571279 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how transitioning from a Western diet to a plant-based diet affects metabolic and molecular responses in adults with prediabetes. It focuses on understanding the differences in insulin sensitivity improvements between men and women when adopting a plant-based diet rich in myoinsitol and D-chiro inositol. The research will explore the pathways through which these dietary changes influence skeletal muscle inositol metabolites and overall insulin sensitivity. Participants will be monitored for changes in their metabolic health over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 30-55 with prediabetes, a body mass index of 27 or higher, and who currently follow a Western diet.
Not a fit: Patients who are already diagnosed with diabetes or those taking medications that affect insulin sensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary approach to significantly improve insulin sensitivity and prevent the progression of diabetes in at-risk individuals.
How similar studies have performed: Previous studies have shown promising results regarding the benefits of plant-based diets on metabolic health, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- University of Kentucky CCTS — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Jean L Fry, PhD — University of Kentucky
- Study coordinator: Jean L Fry, PhD
- Email: jean.fry@uky.edu
- Phone: 859-562-2778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.