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

NCT06817252 | Recruiting

• 1 other identifier: UNLV-2024-385
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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; Inflammation Biomarkers; Dietary Quality; Body Composition Measurement; Waist Circumference; Anthropometrics: Height and Weight

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change in HemoglobinA1c

  Fasting HemoglobinA1C percentage measured via Afinion AS100 Analyzer (point of care device)

  Baseline and 12-Week Study Visits: 12 weeks

• Change in Blood Glucose Levels

  Fasting Blood Glucose Levels Measured with a Glucometer

  Baseline, 6- and 12-Week Study Visits: 12 weeks

• Change in Plasma Insulin Levels

  Fasting Plasma Insulin Levels measured via ELISA

  Baseline, 6- and 12-Week Study Visits: 12 weeks

Secondary Outcomes (26)

• Change in blood pressure

  Baseline, 6- and 12-Week Study Visits: 12 weeks

• Changes in Arterial Stiffness-Pulse Wave Velocity

  Baseline, 6- and 12-Week Study Visits: 12 weeks

• Changes in Arterial Stiffness-Augmentation Index

  Baseline, 6-Week, and 12-Week Study Visits: 12 Weeks

• Changes in Lipid Profiles

  Baseline, 6- and 12-Week Study Visits: 12 weeks

• Change in Oxidized-LDL

  Baseline, 6- and 12-Week Study Visits: 12 weeks

Other Outcomes (2)

• Changes in Glucose Time-in-Range and Peak Glucose

  Pre-Baseline and Pre-12-Week Study Visits: 14 days, 7 prior to the Baseline and 12-Week Study Visits

• Changes in Physical Activity and Sleeping Patterns via Wearable Device

  Pre-Baseline and Pre-12-Week Study Visits: 14 days, 7 prior to the Baseline and 12-Week Study Visits

Study Arms (2)

Mediterranean Diet Nutrition Education

ACTIVE COMPARATOR

Behavioral: Mediterranean Diet Nutrition Education

Mediterranean Diet Nutrition Education with Baked White Potatoes

EXPERIMENTAL

Behavioral: Mediterranean Diet Nutrition Education with Baked White Potato

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

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.

Mediterranean Diet Nutrition Education with Baked White Potatoes

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• Alliance for Potato Research and Education: collaborator

Study Sites (2)

Department of Kinesiology and Nutrition Sciences

Las Vegas, Nevada, 89154, United States

NOT YET RECRUITING

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Hypertension; Body Weight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neda S Akhavan, PhD, RD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study does not involve aType of Drug, Biological/Vaccine, or Combination Product. This is a behavioral intervention focusing on a Mediterranean Diet Nutrition Education with or without baked potatoes.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 10, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)