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NCT06817252
How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes
Conditions: Prediabetes, Lipid Profile, Hypertension, Glycemic Control, Arterial Stiffness, Blood Pressure, Inflammation Biomarkers, Dietary Quality, Body Composition Measurement, Waist Circumference, Anthropometrics: Height and Weight
Sex: All
Ages: 45 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: University of Nevada, Las Vegas
Location: Department of Kinesiology and Nutrition Sciences Las Vegas Nevada
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.
Eligibility Criteria
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 (\
Source: ClinicalTrials.gov (NCT06817252). StuddyBuddy aggregates publicly available trial information.