Mediterranean Diet with Potatoes for Prediabetes
(MEDPOT-PREDM Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot change or add new medications during the study. If you are using insulin or certain other medications, you may not be eligible to participate.
What data supports the effectiveness of the Mediterranean Diet with Potatoes treatment for prediabetes?
Is the Mediterranean Diet with Potatoes safe for humans?
Research suggests that including potatoes in a balanced diet does not negatively impact heart health or gut health in adults with metabolic syndrome, and potatoes can be a good source of nutrients like fiber, potassium, and magnesium. However, consuming large amounts of processed potatoes, like French fries, may increase the risk of type 2 diabetes.678910
How does the Mediterranean Diet with Potatoes treatment for prediabetes differ from other treatments?
The Mediterranean Diet with Potatoes treatment is unique because it combines the benefits of a Mediterranean diet, known for its heart-healthy fats and plant-based foods, with potatoes, which are often considered high in carbohydrates. This approach aims to manage blood sugar levels and insulin resistance by incorporating potatoes in a way that aligns with the Mediterranean diet's principles, potentially offering a novel dietary strategy for prediabetes.79111213
Research Team
Neda S Akhavan, PhD, RD
Principal Investigator
University of Nevada, Las Vegas
Eligibility Criteria
This trial is for adults with pre-diabetes, particularly from diverse racial and ethnic backgrounds. They should have certain health markers like a specific waist measurement, lipid profile, and blood pressure. The study seeks individuals interested in learning about the Mediterranean diet, possibly with conditions like PCOS or impaired glucose tolerance.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Baseline
Placement of continuous glucose monitor and wearable devices for assessments
Treatment
Participants receive BP+MEDNE or MEDNE for 12 weeks with assessments at Baseline, 6, and 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Mediterranean Diet Nutrition Education
- Mediterranean Diet Nutrition Education with Baked White Potato
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nevada, Las Vegas
Lead Sponsor
Alliance for Potato Research and Education
Collaborator