T2DNCT07229482
Potatoes, Type 2 Diabetes, and Cardiometabolic Health
A study of T2D and Blood Pressure, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- T2D, Blood Pressure, Cardiometabolic Health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
Dennis Cladis, PhD, 540-231-5208, dcladis@vt.edu
Elaina Marinik, PhD, 540-231-0923, emarinik@vt.edu
About this study
Official title: Cardiometabolic Effects of a Potato-rich Diet in Older Adults at Increased Risk of Developing Type 2 Diabetes: A Randomized Controlled Feeding Study
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
- Being tested
- Controlled diet: Potato-rich healthy dietary pattern, Controlled diet: Typical Western-style dietary pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled diet: Potato-rich healthy dietary patternOther
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 patternOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Potato-rich healthy diet pattern | Experimental | Following a 2-week eucaloric lead-in diet, participants will be provided and consume a potato-rich healthy dietary pattern for 12 weeks. Receives: Other: Controlled diet: Potato-rich healthy dietary pattern |
| Typical Western-style dietary pattern | Active comparator | Following a 2-week eucaloric lead-in diet, participants will be provided and consume a typical Western-style dietary pattern for 12 weeks. Receives: Other: Controlled diet: Typical Western-style dietary pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
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).
Measured: 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
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).
Measured: 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
24-hour glucose control (24-hour AUC) will be assessed using continuous glucose monitoring for a 7-day period.
Measured: 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
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.
Measured: 20-minute measurement in the laboratory, 2 timepoints (baseline, post 12 week intervention diets)
Secondary outcomes (3)
Change in inflammatory biomarker tumor necrosis factor alpha from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
Tumor necrosis factor alpha will be measured in fasting blood samples via ELISA kits.
Measured: 5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)
Change in inflammatory biomarker interleukin-6 from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
Inflammatory biomarker interleukin-6 will be measured in fasting blood samples via ELISA kits.
Measured: 5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)
Change in inflammatory biomarker monocyte chemoattractant protein-1 from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
Inflammatory biomarker monocyte chemoattractant protein-1 will be measured in fasting blood samples via ELISA kits.
Measured: 5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start27 Aug 2026
- Primary completionOct 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Cladis, Virginia Polytechnic Institute and State University
- Investigators
- Dennis Cladis, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229482
- Sponsor's protocol ID
- 25-897
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Effects of a Potato-rich Diet in Older Adults at Increased Risk of Developing Type 2 Diabetes: A Randomized Controlled Feeding Study
- ClinicalTrials.gov ID
- NCT07229482
- Acronym / sponsor ID
- 25-897
- Conditions
- T2D, Blood Pressure, Cardiometabolic Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potato-rich healthy diet pattern | Experimental | Other: Controlled diet: Potato-rich healthy dietary patternFollowing a 2-week eucaloric lead-in diet, participants will be provided and consume a potato-rich healthy dietary pattern for 12 weeks. |
| Typical Western-style dietary pattern | Active comparator | Other: Controlled diet: Typical Western-style dietary patternFollowing a 2-week eucaloric lead-in diet, participants will be provided and consume a typical Western-style dietary pattern for 12 weeks. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled diet: Potato-rich healthy dietary patternFollowing 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 | Potato-rich healthy diet pattern |
| Controlled diet: Typical Western-style dietary patternFollowing 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. | Other | Typical Western-style dietary pattern |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis Cladis, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of T2D and Blood Pressure, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Cladis, PhD (540-231-5208, dcladis@vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.