Recruiting

Mediterranean Diet

Sponsor:

University of Nevada, Las Vegas

Code:

NCT06817252

Conditions

Prediabetes

Lipid Profile

Hypertension

Glycemic Control

Arterial Stiffness, Blood Pressure

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Mediterranean Diet Nutrition Education

Mediterranean Diet Nutrition Education with Baked White Potato

Study Details

Brief summary:

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.

Conditions

Prediabetes

Lipid Profile

Hypertension

Glycemic Control

Arterial Stiffness, Blood Pressure

Study ID

NCT06817252

Start date

Apr 24, 2025

Status verified date

Jan, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and postmenopausal women within the Las Vegas/Henderson NV area
  • Ages 45-80 years
  • BMI between 25-40 kg/m2
  • HbA1c between 5.7-6.4%
  • 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)
  • Individuals who are considered "non-frequent" white potato consumers (<2 servings of baked potatoes/week)
  • Individuals from all races, genders, sexual identities, and religions will be included
  • 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)

Exclusion Criteria:

  • Individuals with uncontrolled hypertension (≥160/100mmHg), active cancer, asthma, thyroid, kidney, liver, or pancreatic diseases
  • Individuals who are currently using insulin, on dialysis, changing/adding hypoglycemic, anti-hypertensive, and hypocholesterolemic medication within ≤3 months (or throughout the study)
  • Individuals participating in weight loss programs or another clinical trial
  • Individuals who start smoking
  • Individuals who have unstable metabolic or chronic diseases
  • Individuals who may have allergies to potatoes
  • Woman who are currently pregnant, think they may be pregnant, or who is nursing cannot participate (women must be postmenopausal)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mediterranean Diet Nutrition Education

experimental: Mediterranean Diet Nutrition Education with Baked White Potatoes

Interventions

Mediterranean Diet Nutrition Education

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

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.

Primary outcome measure

  • Change in HemoglobinA1c [ Time Frame: Baseline and 12-Week Study Visits: 12 weeks ]
  • Change in Blood Glucose Levels [ Time Frame: Baseline, 6- and 12-Week Study Visits: 12 weeks ]
  • Change in Plasma Insulin Levels [ Time Frame: Baseline, 6- and 12-Week Study Visits: 12 weeks ]

Central Contacts and Locations

Central contacts

Neda S Akhavan, PhD, RD

702-708-2580neda.akhavan@UNLV.edu

Sara K Rosenkranz, PhD

702-895-0938sara.rosenkranz@unlv.edu

Locations

University of Nevada Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89154

Contacts

Neda Akhavan, PhD, RD

850-544-6420neda.akhavan@unlv.edu

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Nov 20, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nevada, Las Vegas on 2025-11-20.