Potatoes, Type 2 Diabetes, and Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorVirginia Polytechnic Institute and State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Controlled diet: Potato-rich healthy dietary pattern
Other interventionFollowing 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 pattern
Other interventionFollowing 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Potato-rich healthy diet patternExperimental treatment 1 intervention
Group B: Typical Western-style dietary patternActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
2-hour test in laboratory, 2 timepoints (baseline, 12-weeks post intervention diets)2
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).
Time frame
2-hour test in laboratory, 2 timepoints (baseline, 12-weeks post intervention diets)3
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.
Time frame
7-day measurement during free-living, 2 timepoints (baseline, 12 weeks post intervention diets)4
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.
Time frame
20-minute measurement in the laboratory, 2 timepoints (baseline, post 12 week intervention diets)Secondary outcomes
1
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.
Time frame
5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)2
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.
Time frame
5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)3
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.
Time frame
5-minute blood collection in laboratory, 2 timepoints (baseline, post 12 week intervention diets)Sponsors and contacts
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Source ClinicalTrials.gov