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NCT Number: NCT07229482

Potatoes, Type 2 Diabetes, and Cardiometabolic Health

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.

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Key information

Conditions

T2D Blood Pressure Cardiometabolic Health

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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 or taking antihypertensive medication
  • 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 or lipid-lowering medication usage <6 months

Treatment and study plan

Controlled diet: Potato-rich healthy dietary pattern

Other

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

Other

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 outcomes

  1. 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)

    Glucose tolerance will be assessed using a 2-hour oral glucose tolerance test (OGTT, 75 g glucose load). Blood will be collected at baseline (fasting) and thereafter at 30-minute intervals (5 total measurements in 2 hours).

  2. 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)

    Insulin sensitivity will be assessed using a 2-hour oral glucose tolerance test (OGTT, 75 g glucose load). Blood will be collected at baseline (fasting) and thereafter at 30-minute intervals (5 total measurements in 2 hours).

  3. 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)

    24-hour glucose control (24-hour AUC) will be assessed using continuous glucose monitoring for a 7-day period.

  4. 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)

    Seated, resting blood pressure will be measured via automated sphygmomanometry, according to American Heart Association guidelines. Both diastolic and systolic blood pressures will be measured.

Secondary outcomes

  1. Change in inflammatory biomarker tumor necrosis factor alpha from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet

    Time frame: 5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)

    Tumor necrosis factor alpha will be measured in fasting blood samples via ELISA kits.

  2. Change in inflammatory biomarker interleukin-6 from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet

    Time frame: 5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)

    Inflammatory biomarker interleukin-6 will be measured in fasting blood samples via ELISA kits.

  3. Change in inflammatory biomarker monocyte chemoattractant protein-1 from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet

    Time frame: 5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)

    Inflammatory biomarker monocyte chemoattractant protein-1 will be measured in fasting blood samples via ELISA kits.

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis Cladis, PhD

CONTACT

[email protected]

540-231-5208

Elaina Marinik, PhD

CONTACT

[email protected]

540-231-0923

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

Cardiometabolic Effects of a Potato-rich Diet in Older Adults at Increased Risk of Developing Type 2 Diabetes: A Randomized Controlled Feeding Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Nov 17, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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