How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes
Recruiting · NCT06817252 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Nevada, Las Vegas
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
2 locations listed across 1 US state.
- Department of Kinesiology and Nutrition Sciences - Las Vegas, Nevada, United States
- University of Nevada Las Vegas - Las Vegas, Nevada, United States