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

NCT06571279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

  • Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Interventions

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.

Sponsors & Collaborators

  • Jean L. Fry

    lead OTHER

Principal Investigators

  • Jean L Fry, PhD · University of Kentucky

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2025-11-25
Completion
2025-11-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571279 on ClinicalTrials.gov