RECRUITING

How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes

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 goal of this clinical trial is to is to determine the effects of baked potato with the skin (BP) + nutrition education focused on adherence for a Mediterranean Dietary Pattern (MEDNE) on glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. The main questions it aims to answer are: * Does BP+MEDNE contribute to improvements in indices of glycemic control, vascular function, blood lipids, inflammation/oxidative stress, and body composition? * Does BP+MEDNE contribute to improvements to overall dietary intake and quality? Researchers will compare BP+MEDNE to MEDNE alone to see if BP+MEDNE can improve glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the study site for a Pre-Baseline and Pre-12-Week Study Visit (one week prior to Baseline and 12-Week Study Visits) for placement of placement of a continuous glucose monitor and wearable devices to be removed at Baseline and 12-Week Study Visits. * Be asked to come to the study site for Baseline, 6- and 12-Week Study Visits for assessments of glycemic control and cardiometabolic health. * Be asked to complete 3-Day Food Records throughout the 12 week study period for assessment of dietary quality (5 total) * Receive pre-recorded MEDNE ( which can be accessed via computer device/ipad/smartphone) after Baseline and 6-Week Study Visits. * If randomized to the BP+MEDNE group, participants will receive pre-prepared baked potatoes with the skin for the 12-week study period (every 3 weeks) at Baseline and 6-Week Study Visits and asked to come to the study site for picking up the pre-prepared baked potatoes at weeks 3 and 9 of the study period.

Official Title

Effects of a Mediterranean Dietary Pattern With White Potato on Cardiometabolic Health in Adults With Pre-Diabetes

Quick Facts

Study Start:2025-04-24
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06817252

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:45 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and postmenopausal women within the Las Vegas/Henderson NV area
  2. * Ages 45-80 years
  3. * BMI between 25-40 kg/m2
  4. * Fasting blood glucose between 100-126 g/dL, HbA1c between 5.7-6.4%
  5. * Individuals from different demographic backgrounds (i.e., American Indian or Alaska Native, Caucasians, Asian, Black or African-American, Native Hawaiian, Hispanic, Latino or Pacific Islander)
  6. * Individuals who are considered "non-frequent" white potato consumers (\<2 servings of baked potatoes/week)
  7. * Individuals from all races, genders, sexual identities, and religions will be included
  8. * Individuals must follow certain guidelines, including avoiding new medications during the study or significant changes to lifestyle factors (e.g. beginning to smoke or exercise more or less than usual)
  1. * Individuals with uncontrolled hypertension (≥160/100mmHg), active cancer, asthma, thyroid, kidney, liver, or pancreatic diseases
  2. * Individuals who are currently using insulin, on dialysis, changing/adding hypoglycemic, anti-hypertensive, and hypocholesterolemic medication within ≤3 months (or throughout the study)
  3. * Individuals participating in weight loss programs or another clinical trial
  4. * Individuals who start smoking
  5. * Individuals who have unstable metabolic or chronic diseases
  6. * Individuals who may have allergies to potatoes
  7. * Woman who are currently pregnant, think they may be pregnant, or who is nursing cannot participate (women must be postmenopausal)

Contacts and Locations

Study Contact

Neda S Akhavan, PhD, RD
CONTACT
702-708-2580
neda.akhavan@UNLV.edu
Sara K Rosenkranz, PhD
CONTACT
702-895-0938
sara.rosenkranz@unlv.edu

Principal Investigator

Neda S Akhavan, PhD, RD
PRINCIPAL_INVESTIGATOR
University of Nevada, Las Vegas

Study Locations (Sites)

Department of Kinesiology and Nutrition Sciences
Las Vegas, Nevada, 89154
United States
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
United States

Collaborators and Investigators

Sponsor: University of Nevada, Las Vegas

  • Neda S Akhavan, PhD, RD, PRINCIPAL_INVESTIGATOR, University of Nevada, Las Vegas

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 Date2025-04-24
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-04-24
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • White Potato
  • Prediabetes
  • Mediterranean Diet
  • Cardiometabolic Health
  • Dietary Quality

Additional Relevant MeSH Terms

  • Prediabetes
  • Lipid Profile
  • Hypertension
  • Glycemic Control
  • Arterial Stiffness, Blood Pressure
  • Inflammation Biomarkers
  • Dietary Quality
  • Body Composition Measurement
  • Waist Circumference
  • Anthropometrics: Height and Weight