An interventional study of Mediterranean Diet Nutrition Education and Mediterranean Diet Nutrition Education with Baked White Potato in Prediabetes, Lipid Profile and Hypertension, sponsored by University of Nevada, Las Vegas. Recruiting at 2 sites in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Nevada, Las Vegas · Not applicable, Interventional, and Prevention
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:
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:
Study Overview: Investigators will recruit 60 adults with pre-diabetes from different demographic backgrounds, between the ages of 45 and 80 years to participate in a 12-week randomized controlled trial (RCT) examining baked potato with the skin (BP) + nutrition education focused on adherence for a Mediterranean Dietary Pattern (MEDNE) compared to MEDNE alone. Potential participants will be recruited from the metropolitan Las Vegas area through campus and community advertisements including flyers, newspaper articles, social media, and public events. Investigators will randomize eligible, consenting participants to receive either the BP+MEDNE or MEDNE in a 1:1 ratio. Investigators will use a computer-generated randomization method to manage the random assignment of either group.
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 history and dietary habits. Potential participants will be invited to report to the clinical facilities in the Health Sciences Building at UNLV (study site) for their first on-site visit (and all subsequent visits if the participant qualifies) to ascertain eligibility (screening study visit). This pre-screening interview will occur prior to participants consenting (which occurs at the in person screening study visit).
Screening Study Visit: Potential participants who inquire about the study by calling the recruitment phone line will be given a brief overview of the study and pre-screened by telephone 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. Potentially eligible participants will be invited to report to the study site for their first on-site visit for screening (and all subsequent visits if the participant qualifies) to ascertain eligibility (Screening Study Visit). During the first in-person study visit for screening, the potential participants will be provided with verbal and written explanations of the project and will have any questions regarding the study answered by trained research personnel during the informed consent process. Consenting participants will be asked to sign an informed consent document (with a copy provided to the participant to take home). To confirm eligibility, the Screening Study Visit will consist of measurements of HbA1c (Afinion HbA1c Point of Care) via finger stick blood draw to confirm pre-diabetes, in addition to anthropometrics, blood pressure, and questions regarding medical history and medication use (fasting blood glucose via Libre Flash Glucose Monitoring Glucometer will be assessed but not as an eligibility criteria). Potential participants will also complete a component of a 7-day food frequency questionnaire, to indicate whether individuals frequently consume baked white potatoes. If participants are considered "non-frequent" white potato consumers, they will be included in the study and asked to come for subsequent visits and study visits. Participants who are not eligible will be thanked for their time and participation and told the specific reasoning for why they do not meet the inclusion criteria. Eligible participants will be asked to complete a three-day food record using NCI's Automated Self-Administered 24-Hour Dietary Assessment Tool to assess typical dietary intake and dietary quality (Healthy Eating Index [HEI]-2020 scoring), prior to their Baseline Study Visit at participants homes via a computer, ipad, or smartphone. The Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) is a web-based dietary recall system developed by the National Cancer Institute. It allows participants to self-report their dietary intake over the past 24 hours using a user-friendly interface that prompts for detailed food and beverage consumption. The tool can be distributed via a unique web link provided to participants, enabling remote data collection without requiring in-person visits.
Pre Baseline and 12-Week Visits: One week prior to the Baseline and 12-Week Study Visits, eligible participants will be asked to come to the study site to have placement of a continuous glucose monitor from training research staff (Dexcom G7) and wearable devices (ActiGraph Accelerometry) for assessments of real-time blood glucose levels, physical activity, and sleeping patterns. At their Baseline and 12-Week Study Visits, trained research staff will remove the Dexcom CGM from the participant and discard it. Similarly at their Baseline and 12-Week Study Visits, the Actigraph wearable device will be removed from trained research staff.
Baseline, 6- and 12-Week Study Visits: At the Baseline, 6-, and 12-Week Study Visits participants will be asked to come fasted to the study site (12 hours after the abstinence from caffeine and 24 hours after the last bout of moderate/heavy physical activity); vascular assessments (blood pressure, Pulse Wave Velocity, Pulse Wave Analysis) will be measured followed by body composition (Bioelectrical Impedance Analysis), finger prick blood draw (fasting blood glucose and HbA1c), venous blood draw (lipid profiles, inflammatory, and oxidative stress biomarkers), anthropometrics (height, weight, and waist/hip circumference), assessment of fruit and vegetable intake via Raman Spectroscopy, assessment of physical activity patterns (Five-City Project Physical Activity Recall), MD adherence (Mediterranean Diet Adherence Screener), and sleep quality (Pittsburg Sleep Quality Index). After assessments of outcome measurements at Baseline and 6-Week Study Visits (not at the 12-Week Study Visit), participants will be provided with BP+MEDNE or MEDNE (comparative control). All participants will be provided with MEDNE. In addition to all assessments mentioned for all study visits, at the 12-Week Study Visit there will be assessment of dietary and/or nutrition education acceptability and feasibility.
Dietary Assessments Throughout The Study Period (at week 1, 4, 8, and 12): Participants will be asked to complete a three-day food record using NCI's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool to assess typical dietary intake and diet quality (using HEI-202075) during week 1, 4, 8, and 12 of the study period. This food record can be completed at participants' homes via a computer, ipad or smartphone.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →University of Nevada, Las Vegas is the lead sponsor of 75 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Mediterranean Diet Nutrition Education
Behavioral: Mediterranean Diet Nutrition Education with Baked White Potato
Participants 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.
Participants 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)
Time frame: Baseline, 6-, and 12-Week Study Visits: 12 weeks
Change in Blood Glucose Levels
Fasting Blood Glucose Levels Measured with a Glucometer
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Change in Plasma Insulin Levels
Fasting Plasma Insulin Levels measured via ELISA
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Change in blood pressure
Fasted diastolic and systolic blood pressure, measured via OMRON automated blood pressure device
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
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).
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
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 (%)
Time frame: Baseline, 6-Week, and 12-Week Study Visits: 12 Weeks
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
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Change in Oxidized-LDL
Fasted oxidized LDL will be measured via ELISA
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in waist and hip circumferences
Waist and hip circumference changes measured in centimeters.
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Change in body fat %
Body fat % measured via Bioelectrical Impedance Analysis (Seca BIA Platform mBCA 554 Medical Body Composition Analyzer)
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Dietary Quality
Dietary Quality measured via Health Eating Index-2020 from three-day food records using NCI's Automated Self-Administered 24-Hour Dietary Assessment Tool. The index score will be from 0-100, with 0 indicating poorest diet quality and 100 excellent.
Time frame: Pre-Baseline, and weeks 1, 4, 8, and 12 of the study period: 13 weeks (due to assessment prior to Baseline)
Changes in Fruit and Vegetable Intake Adherence
Assessment of fruit and vegetable intake will be measured via Raman Spectroscopy (VeggieMeter)
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Physical Activity Patterns
Assessment of physical activity patterns via Five-City Project Physical Activity Recall
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Sleep Quality
Assessment of sleep quality measured via Pittsburg Sleep Quality Index wich is a questionnaire used to assess the quality and patterns of sleep over a one-month period, measuring factors like sleep duration, sleep disturbances, and daytime dysfunction. The scores are typically presented as a global score, ranging from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Arterial Stiffness- Central Systolic Blood Pressure
Fasted measured of Central Systolic Blood Pressure (cSBP) measured in mmHg (millimeters of mercury) via SphygmoCor XCEL.
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Arterial Stiffness-Central Pulse Pressure
Fasted measured of Central Pulse Pressure measured in mmHg (millimeters of mercury) via SphygmoCor XCEL.
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Arterial Stiffness-Augmented Pressure
Fasted measured of Augmented Pressure measured in mmHg (millimeters of mercury) via SphygmoCor XCEL
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Arterial Stiffness-Subendocardial Viability Ratio
Fasted measured of arterial stiffness via pulse wave analysis (SphygmoCor XCEL) with measure of Subendocardial Viability Ratio expressed as a percentage (%)
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes In Arterial Stiffness-Transit Time
Fasted measured of arterial stiffness via transit in milliseconds (SphygmoCor XCEL).
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in body weight
Body weight will be measured in kilograms with a weighing scale
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in Body Mass Index
Body Mass Index will be assessed with a participants height in meters and body weight in kilograms, in the unit of kg/m2
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Assessment of Height
Height will be assessed in meters (for assessment of BMI at future visits and inclusion criteria)
Time frame: Screening
Changes in high sensitivity C-Reactive Protein
Fasted measure of plasma high sensitivity C-Reactive Protein in mg/L measured via ELISA
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes in tumor necrosis factor-alpha
Fasted measure of plasma tumor necrosis factor-alpha in pg/mL measured via ELISA
Time frame: Baseline, 6-Week, and 12-Week Study Visits: 12 Weeks
Changes in soluble intercellular adhesion molecule-1
Fasted measure of soluble intercellular adhesion molecule-1 in ng/mL measured via ELISA
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Changes In Dietary Intake
Dietary intake measured from three-day food records using NCI's Automated Self-Administered 24-Hour Dietary Assessment Tool, will be measured throughout the study period to indicate any changes in overall macro and micro nutrient intake between the treatment and comparative control group.
Time frame: Pre-Baseline, and weeks 1, 4, 8, and 12 of the study period: 13 weeks (due to assessment prior to Baseline)
Changes in barriers to Mediterranean Diet Adherence
Measurements of barriers to Mediterranean Diet Adherence (Barrier Analysis Questionnaire) which are questions that identifies factors that prevent individuals from fully adhering to the Mediterranean diet, such as cultural, economic, or personal obstacles
Time frame: Baseline, 6- and 12-Week Study Visits: 12 weeks
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.
Time frame: Pre-Baseline and Pre-12-Week Study Visits: 14 days, 7 prior to the Baseline and 12-Week Study Visits
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.
Time frame: Pre-Baseline and Pre-12-Week Study Visits: 14 days, 7 prior to the Baseline and 12-Week Study Visits
Plan to share: No — Individual Participant Data (IPD) will not be shared because the study did not obtain participant consent for data sharing, and there are concerns regarding the protection of participant privacy and confidentiality. Additionally, institutional and regulatory policies restrict data sharing, and the data are not intended for broader dissemination.
No publications or documents are linked to this record.
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University of Nevada, Las Vegas