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.
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 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
Parallel
Mediterranean Diet Nutrition Education
BehavioralParticipants 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 recipes), and techniques for overcoming barriers to following a Mediterranean dietary pattern.
Mediterranean Diet Nutrition Education with Baked White Potato
BehavioralParticipants randomized to receive the Mediterranean Diet Nutrition Education with Baked White Potatoes will similarly receive the same pre-recorded education sessions (lasting approximately 1 hour) and supporting resources 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 .
Change in HemoglobinA1c
Fasting HemoglobinA1C percentage measured via Afinion AS100 Analyzer (point of care device)
Change in Blood Glucose Levels
Fasting Blood Glucose Levels Measured with a Glucometer
Change in Plasma Insulin Levels
Fasting Plasma Insulin Levels measured via ELISA
Change in blood pressure
Fasted diastolic and systolic blood pressure, measured via OMRON automated blood pressure device
Changes in Arterial Stiffness-Pulse Wave Velocity
Fasted measured of arterial stiffness via carotid-femoral and aortic pulse wave velocity (cfPWV) in meters per second (m/s) (SphygmoCor XCEL).
Changes in Arterial Stiffness-Augmentation Index
Fasted measured of arterial stiffness via pulse wave analysis (SphygmoCor XCEL) with measure of Augmentation Index (AIx) expressed as a percentage (%)
Changes in Lipid Profiles
Measure of fasted lipid profiles (total cholesterol, triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol) all measured in milligrams per deciliter (mg/dL) via Piccolo Xpress chemistry analyzer
Changes in Glucose Time-in-Range and Peak Glucose
Glucose Time-in-Range and Peak Glucose (mean, nighttime, and daytime glucose levels, in addition to glucose variability) measured via Continuous Glucose Monitoring (Dexcom G7) which will be assessed in units of milligrams per deciliter (mg/dL) for blood glucose levels throughout the days.
Changes in Physical Activity and Sleeping Patterns via Wearable Device
Physical Activity and Sleeping Patterns assessed vis wearable device (ActiGraph Accelerometry) which is used to objectively assess physical activity and sleep patterns by measuring movement through sensors that track acceleration. The data collected includes metrics like step count, intensity of activity, and sleep duration or quality.
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University of Nevada, Las Vegas
Lead sponsor
Alliance for Potato Research and Education
Collaborator
