Assessing the Impact of a Plant-Based Diet for Diabetes Prevention
- Conditions
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- Interventions
- Other: Plant-based diet
- Registration Number
- NCT06571279
- Lead Sponsor
- Jean L. Fry
- 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 resistance. The Western diet contributes to chronic metabolic inflammation often leading to the development of metabolic diseases. There is known metabolic improvement among men compared to women when following a plant-based diet or intensive lifestyle modifications. Through this study we look to identify the pathways in which plant-based diet impact skeletal muscle inositol metabolites among sexes (men vs. women) and improve insulin sensitivity.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Plant-based diet Plant-based diet 4 weeks of plant-based meals and snacks.
- Primary Outcome Measures
Name Time Method Insulin sensitivity (glucose infusion rate) 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. This gold standard test for IS will be performed at baseline and post-intervention with support of the COBRE Phenotyping core. After ≥8 hour fast, participants will be admitted to our Center for Clinical and Translational Science (CCTS) and two IVs inserted; one for infusion, the other for blood draws (see Phenotyping core). The primary outcome is the glucose infusion rate (GIR), a direct measure of whole body IS, which will enable us to detect even small changes in IS in response to the intervention. COBRE mentor Dr. Kern is proficient in use of these methods The primary clinical outcome is the change in GIR from post run-in to post intervention.
Skeletal muscle d-chiroinositol content 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. Muscle samples will be homogenized, then inositol compounds will be extracted using solvents. In the prepared samples, D-chiroinositol content will be assessed by a commercial service using LC-MS/MS.
- Secondary Outcome Measures
Name Time Method Phosphorylation status of insulin signaling molecules in skeletal muscle 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. Upon insulin stimulation, insulin-responsive signaling proteins are phosphorylated to initiate downstream effects. The ratio of phosphorylated and unphosphorylated, as well as total protein, per standard unit of skeletal muscle will be determined.
Absolute change in visceral fat (g) 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. Computed tomography will be used to measure visceral fat
Fasting blood glucose 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. Baseline measure of fasting blood glucose are measured via YSI before the start of the OGTT
Trial Locations
- Locations (1)
University of Kentucky CCTS
🇺🇸Lexington, Kentucky, United States