UK Center for Clinical and Translational Science

Assessing the Impact of a Plant-Based Diet for Diabetes Prevention

Purpose

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.

Condition

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Eligibility

Eligible Ages: Between 30 Years and 55 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Other Plant-based diet	5 weeks of plant-based meals and snacks.	Other: Plant-based diet Standard plant-based meals will be provided directly to participants. The dietary intervention will begin with a one-week Western diet run-in; hereafter, participants will consume plant-based meals for approximately 5 weeks. Total energy provided will be equal to REE X 1.4 to account for light physical activity to support weight maintenance. High-inositol snacks will be provided to meet energy needs. Meals and snacks combined will provide a minimum of 20mg total inositol/kg body weight. For example, a 200lb participant will consume 1.8g daily, which is consistent with doses used in prior studies.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky CCTS
Lexington, Kentucky 40536

Contact:
Jean Fry, Assistant Professor, PhD
859-562-2778
jean.fry@uky.edu

More Details

NCT ID: NCT06571279
Status: Recruiting
Sponsor: Jean L. Fry

Study Contact

Jean L Fry, PhD
859-562-2778
jean.fry@uky.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.