Potatoes, Type 2 Diabetes, and Cardiometabolic Health

Virginia Polytechnic Institute and State University

Status: Begins enrollment this month

Conditions: Cardiometabolic Health; T2D; Blood Pressure

Treatments: Other: Controlled diet: Typical Western-style dietary pattern; Other: Controlled diet: Potato-rich healthy dietary pattern

Study type: Interventional

Funder types: Other

Identifiers

NCT07229482

25-897

Details and patient eligibility

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. 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Potato-rich healthy diet pattern

Experimental group

Description:

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a potato-rich healthy dietary pattern for 12 weeks.

Treatment:

Other: Controlled diet: Potato-rich healthy dietary pattern

Typical Western-style dietary pattern

Active Comparator group

Description:

Following a 2-week eucaloric lead-in diet, participants will be provided and consume a typical Western-style dietary pattern for 12 weeks.

Treatment:

Other: Controlled diet: Typical Western-style dietary pattern