Status:
COMPLETED
Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
Lead Sponsor:
Jean L. Fry
Conditions:
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
Eligibility:
All Genders
30-55 years
Phase:
NA
Brief 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.
Detailed Description
Plant-based diets that are abundant in myoinsitol and D-chiro inositol (MI and DCI) increase insulin sensitivity by promotion of insulin signaling lowering serum insulin and improving insulin resistan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06571279
Start Date
October 14 2024
End Date
November 25 2025
Last Update
December 11 2025
Active Locations (1)
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1
University of Kentucky CCTS
Lexington, Kentucky, United States, 40536