No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
45 – 80
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
University of Nevada, Las Vegas · Other
Who this trial is looking for
This trial is looking for men and women aged 45-80 with pre-diabetes. Participants will follow a Mediterranean diet that includes baked potatoes and complete assessments at various visits over 12 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am a man or postmenopausal woman.
I am aged 45-80 years.
My BMI is between 25-40.
My HbA1c is between 5.7-6.4%.
I consume baked potatoes less than 2 times a week.
I come from various demographic backgrounds.
I can avoid significant lifestyle changes during the study.
You may not be able to join if
I have uncontrolled hypertension (≥160/100mmHg).
I have active cancer or certain diseases affecting my organs.
I am currently using insulin or on dialysis.
I am participating in a weight loss program or another clinical trial.
I have allergies to potatoes.
I am currently pregnant or nursing.
I have unstable metabolic or chronic diseases.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 i…
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.
Trial Locations
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State
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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,…
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)
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