NCT07229482 · Virginia Polytechnic Institute and State University
Potatoes, Type 2 Diabetes, and Cardiometabolic Health
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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 measures
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).
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).
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Blacksburg, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations