Clinical trial NCT06817252: How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes
Official title: Effects of a Mediterranean Dietary Pattern With White Potato on Cardiometabolic Health in Adults With Pre-Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes
Lipid Profile
Hypertension
Glycemic Control
Arterial Stiffness, Blood Pressure
Inflammation Biomarkers
Dietary Quality
Body Composition Measurement
Waist Circumference
Anthropometrics: Height and Weight
Keywords: White Potato
Prediabetes
Mediterranean Diet
Cardiometabolic Health
Dietary Quality
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Alliance for Potato Research and Education
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study does not involve aType of Drug, Biological/Vaccine, or Combination Product. This is a behavioral intervention focusing on a Mediterranean Diet Nutrition Education with or without baked potatoes.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 fasting blood glucose (ACCU-CHECK Glucometer) and 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. Potential participants will also complete 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 (between 7:00-10:00 A.M., 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), nutrition knowledge (General Nutrition Knowledge Questionnaire), MD adherence (Mediterranean Diet Adherence Screener), barriers to Mediterranean Diet Adherence (Barrier Analysis Questionnaire), 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.

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
* Fasting blood glucose between 100-126 g/dL, 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)

Primary outcomes:
measure: Change in HemoglobinA1c
timeFrame: Baseline and 12-Week Study Visits: 12 weeks
measure: Change in Blood Glucose Levels
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Change in Plasma Insulin Levels
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Arterial Stiffness-Pulse Wave Velocity
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Arterial Stiffness-Augmentation Index
timeFrame: Baseline, 6-Week, and 12-Week Study Visits: 12 Weeks
measure: Changes in Lipid Profiles
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Change in Oxidized-LDL
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in waist and hip circumferences
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Change in body fat %
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Dietary Quality
timeFrame: Pre-Baseline, and weeks 1, 4, 8, and 12 of the study period: 13 weeks (due to assessment prior to Baseline)
measure: Changes in Nutrition Knowledge
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Fruit and Vegetable Intake Adherence
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Physical Activity Patterns
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Sleep Quality
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Arterial Stiffness- Central Systolic Blood Pressure
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Arterial Stiffness-Central Pulse Pressure
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Arterial Stiffness-Augmented Pressure
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Arterial Stiffness-Subendocardial Viability Ratio
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes In Arterial Stiffness-Transit Time
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in body weight
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in Body Mass Index
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Assessment of Height
timeFrame: Screening
measure: Changes in high sensitivity C-Reactive Protein
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in tumor necrosis factor-alpha
timeFrame: Baseline, 6-Week, and 12-Week Study Visits: 12 Weeks
measure: Changes in soluble intercellular adhesion molecule-1
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes In Dietary Intake
timeFrame: Pre-Baseline, and weeks 1, 4, 8, and 12 of the study period: 13 weeks (due to assessment prior to Baseline)
measure: Changes in Mediterranean Diet Adherence
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
measure: Changes in barriers to Mediterranean Diet Adherence
timeFrame: Baseline, 6- and 12-Week Study Visits: 12 weeks
Other outcomes:
measure: Changes in Glucose Time-in-Range and Peak Glucose
timeFrame: Pre-Baseline and Pre-12-Week Study Visits: 14 days, 7 prior to the Baseline and 12-Week Study Visits
measure: Changes in Physical Activity and Sleeping Patterns via Wearable Device
timeFrame: Pre-Baseline and Pre-12-Week Study Visits: 14 days, 7 prior to the Baseline and 12-Week Study Visits
Locations:
city: Las Vegas
country: United States
facility: Department of Kinesiology and Nutrition Sciences
state: Nevada
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Neda S Akhavan, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: