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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
University of Nevada, Las Vegas
Study ID
NCT06817252
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Mediterranean Diet Nutrition Education — BEHAVIORAL
    Participants randomized to receive the Mediterranean Diet Nutrition Education will receive a pre-recorded education session (lasting approximately 1 hour) they can watch at home after their Baseline and 6-Week Study Visits, which will be created by the PI and Co-I's of the study (who are comprised of Professors who are either Registered Dietitian credentialed or have experience with creating nutrition/physical activity programs), including an explanation of the principles and components of a Mediterranean dietary pattern and its benefits, guidance on recommended intake of various food groups, budget-friendly strategies for incorporation, supporting resources (educational materials and online tools), and techniques for overcoming barriers to following a Mediterranean dietary pattern. Additional educational materials will be provided to participants through computer or web-based sources.
  • Mediterranean Diet Nutrition Education with Baked White Potato — BEHAVIORAL
    Participants randomized to receive the Mediterranean Diet Nutrition Education with Baked White Potatoes will similarly receive a pre-recorded education session (lasting approximately 1 hour) they can watch at home after their Baseline and 6-Week Study Visits (same as the Mediterranean Diet Nutrition Education group). They will also receive will 100 g roasted white russet potatoes with the skin and will be asked to consume the regimen as a part of their meals (breakfast, lunch, dinner) or as a snack throughout the day to contribute to a balanced meal plan. The baked white potato regimen will be pre-portioned (in 100g amounts), stored in the freezer and given in freezer-microwave safe containers. The baked white potato regimen is approximately 100 kilocalories, 22g carbohydrates, and 0.2g of fat . In order to increase participants' compliance, they will be informed of a variety of ways to consume the baked white potato regimen.

Study Details

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.

Key Dates

Start date
Apr 24, 2025
Status verified
Jan 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Mediterranean Diet Nutrition Education
  • Experimental: Mediterranean Diet Nutrition Education with Baked White Potatoes

Primary Outcome Measure

Change in HemoglobinA1c [ Time Frame: Baseline and 12-Week Study Visits: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Department of Kinesiology and Nutrition SciencesLas VegasNevada89154
Neda S Akhavan, PhD, RD
[email protected]
8505446420
University of Nevada Las VegasLas VegasNevada89154
Neda Akhavan, PhD, RD
[email protected]
850-544-6420

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By research site
Department of Kinesiology and Nutrition Sciences· Las Vegas, NVUniversity of Nevada Las Vegas· Las Vegas, NV

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