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 range30 Years – 55 Years

SexALL

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

What they're measuring

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.

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.

Trial details

NCT IDNCT06571279

SponsorJean L. Fry

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-25

View on ClinicalTrials.gov More Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) trials

Who can participate

Age range30 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

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.