Potatoes, Type 2 Diabetes, and Cardiometabolic Health

NCT07229482 | Not Yet Recruiting

• 1 other identifier: 25-897
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  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

  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

  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

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

Study Arms (2)

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.

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.

Other: Controlled diet: Typical Western-style dietary pattern

Interventions

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.

Potato-rich healthy diet pattern

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.

Typical Western-style dietary pattern

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Location

Study Officials

• Dennis Cladis, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Cladis, PhD

CONTACT

540-231-5208; dcladis@vt.edu

Elaina Marinik, PhD

CONTACT

540-231-0923; emarinik@vt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 17, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)