Recruiting

Potatoes

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT07229482

Conditions

T2D

Blood Pressure

Cardiometabolic Health

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

Interventions

Controlled diet: Potato-rich healthy dietary pattern

Controlled diet: Typical Western-style dietary pattern

Study Details

Brief summary:

Type 2 diabetes (T2D) is a major chronic health condition which increases risk of coronary artery disease, frailty, cognitive decline, and mortality. Additionally, hypertension is a major comorbidity for individuals with T2D, further increasing the risk of adverse cardiovascular outcomes. The prevalence of both conditions increases with advancing age. There is an urgent need to identify new approaches to prevent the development of T2D and improve cardiometabolic health in older adults 50-70 years of age.

Whole white potatoes are an unprocessed food rich in essential nutrients often under-consumed by Americans, including potassium, fiber, magnesium, vitamins C and B6, and phytochemicals. Each of these nutrients individually are associated with cardiometabolic health benefits. Potatoes account for a significant amount of the intake of these nutrients in the US diet and are well-positioned to be a foundational element of a healthy dietary pattern. However, there are few interventional studies evaluating the effect of potatoes on cardiometabolic health, and the evidence from observational studies is mixed, leaving a significant gap in knowledge regarding the potential for potatoes to be included in healthy dietary patterns.

The results of our proposed study will provide foundational data that inform future dietary guidelines regarding the inclusion of white potatoes as part of a healthy US dietary pattern.

Conditions

T2D

Blood Pressure

Cardiometabolic Health

Study ID

NCT07229482

Start date

Aug 27, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 50-70 years
  • Weight stable for previous 3 months (±5% body weight)
  • Sedentary to recreationally active
  • ADA-Risk Screener questionnaire score of at least 5
  • No plans to gain or lose weight or change physical activity level
  • Willing to pick up food daily and consume foods provided for a 14-week period
  • Verbal and written informed consent
  • Estrogen or testosterone use, lipid-lowering or blood pressure medication and thyroid replacement medication is acceptable, if on stable dose for >6 months

Exclusion Criteria:

  • Body mass index >40 m2/kg
  • Diabetes or diabetes medication
  • Weight loss medication or medication influencing glucose metabolism
  • Antibiotic, prebiotic or probiotic use in prior 3 months
  • TCHOL >6.2 mmol/L; TG >4.5 mmol/L
  • Blood pressure (BP) > 159/99 mmHg
  • Diagnosed inflammatory bowel disease
  • Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
  • Vegetarian or vegan
  • Pregnant or plans to become pregnant
  • Food allergies or aversions to diet foods provided
  • Estrogen or testosterone usage, lipid-lowering medication, blood pressure medication usage <6 months

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Potato-rich healthy diet pattern

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a potato-rich healthy dietary pattern for 12 weeks.

active comparator: Typical Western-style dietary pattern

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a typical Western-style dietary pattern for 12 weeks.

Interventions

Controlled diet: Potato-rich healthy dietary pattern

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a potato-rich healthy dietary pattern for 12 weeks. The intervention diet will be eucaloric and matched for macronutrient composition with the control diet. Whole white potatoes will be incorporated into the intervention diet in different forms. This diet will have an healthy eating index (HEI) score of 85.

Controlled diet: Typical Western-style dietary pattern

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a typical Western-style dietary pattern for 12 weeks. The control diet will be potato-free, eucaloric, and matched for macronutrient composition with the intervention diet. This diet will have an healthy eating index (HEI) score of 58.

Primary outcome measure

  • Change in glucose tolerance from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet [ Time Frame: 2-hour test in laboratory, 2 timepoints (baseline, 12-weeks post intervention diets) ]
  • Change in insulin sensitivity from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet [ Time Frame: 2-hour test in laboratory, 2 timepoints (baseline, 12-weeks post intervention diets) ]
  • Change in glucose control (AUC) from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet [ Time Frame: 7-day measurement during free-living, 2 timepoints (baseline, 12 weeks post intervention diets) ]
  • Change in blood pressure from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet [ Time Frame: 20-minute measurement in the laboratory, 2 timepoints (baseline, post 12 week intervention diets) ]

Central Contacts and Locations

Central contacts

Dennis Cladis, PhD

540-231-5208dcladis@vt.edu

Elaina Marinik, PhD

540-231-0923emarinik@vt.edu

Locations

Virginia Polytechnic Institute and State University

Recruiting

Blacksburg, Virginia, United States, 24061

Contacts

Dennis Cladis, PhD

540-231-5208dcladis@vt.edu

Elaina Marinik, PhD

540-231-0923emarinik@vt.edu

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2026-09-03.