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

Effects of a Mediterranean Dietary Pattern With White Potato on Cardiometabolic Health in Adults With Pre-Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews, Questionnaires, Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Prescreen Interview: Potential participants who inquire about the study by calling the recruitment phone line, will be given a brief overview of the study and will be pre-screened by telephone interview to determine whether they should be invited for the in-person screening visit."
  • "Eligibility will be based on inclusion/exclusion criteria and responses to questions about medical and diet history during the pre-screen phone interview."
  • "Potential participants will also complete a component of a 7-day food frequency questionnaire, to indicate whether individuals frequently consume baked white potatoes."
  • "Similarly at their Baseline and 12-Week Study Visits, the Actigraph wearable device will be removed from trained research staff."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 (\<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)

Study sites (2)

NV