RECRUITING

Impact of Plant Diet for Diabetes Prevention

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Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-14
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06571279

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index greater than or equal to 27
  2. * High waist circumference (women greater than or equal to 35"; men greater than or equal to 40")
  3. * 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)
  4. * Physical activity below national guidelines
  5. * Aged 30-55 (premenopausal for women)
  6. * Following a Western diet
  1. * Diabetes diagnosis
  2. * Take medications that may affect insulin sensitivity
  3. * More than 5% weight change within 6 months of screening
  4. * History of bariatric surgery
  5. * Report any dietary supplement, medication, or medical condition known to significantly affect weight or metabolism
  6. * Take hormone replacement therapy
  7. * Consume 3 or more servings of combined fruit and vegetables daily and/or 3 or more servings of whole grains daily
  8. * Any food allergy more severe than grade 1 on the CoFAR Grading Scale for Systemic Allergic Reactions, Version 3.0 or allergy to lidocaine

Contacts and Locations

Study Contact

Jean L Fry, PhD
CONTACT
859-562-2778
jean.fry@uky.edu
Kayla R Anderson, MS
CONTACT
kan266@uky.edu

Principal Investigator

Jean L Fry, PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

University of Kentucky CCTS
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: Jean L. Fry

  • Jean L Fry, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-14
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-10-14
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)