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Purpose

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

Eligibility

Eligible Ages
Between 50 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.
Active Comparator
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.
  • 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.

Recruiting Locations

Virginia Polytechnic Institute and State University
Blacksburg, Virginia 24061
Contact:
Dennis Cladis, PhD
540-231-5208
dcladis@vt.edu

More Details

Status
Recruiting
Sponsor
Virginia Polytechnic Institute and State University

Study Contact

Dennis Cladis, PhD
540-231-5208
dcladis@vt.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.