Potatoes, Type 2 Diabetes, and Cardiometabolic Health

NCT ID: NCT07229482

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2029-03-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Controlled diet: Potato-rich healthy dietary pattern

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Controlled diet: Typical Western-style dietary pattern

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Dennis Cladis

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Cladis, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, United States

Countries

United States

Central Contacts

Dennis Cladis, PhD

Role: CONTACT

dcladis@vt.edu

540-231-5208

Elaina Marinik, PhD

Role: CONTACT

emarinik@vt.edu

540-231-0923

Facility Contacts

Dennis Cladis, PhD

Role: primary

dcladis@vt.edu

540-231-5208

Elaina Marinik, PhD

Role: backup

emarinik@vt.edu

540-231-0923

Other Identifiers

25-897

Identifier Type: -

Identifier Source: org_study_id