Cardiometabolic Effects of a Potato-rich Diet in Older Adults at Increased Risk of Developing Type 2 Diabetes: A Randomized Controlled Feeding Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in glucose tolerance from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 or blood pressure medication and thyroid replacement medication is acceptable, if on stable dose for >6 months
排除标准
- •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
- •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, lipid-lowering medication, blood pressure medication usage <6 months
研究组 & 干预措施
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.
干预措施: Controlled diet: Potato-rich healthy dietary pattern (Other)
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.
干预措施: Controlled diet: Typical Western-style dietary pattern (Other)
结局指标
主要结局
Change in glucose tolerance from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
时间窗: 2-hour test in laboratory, 2 timepoints (baseline, 12-weeks post intervention diets)
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).
Change in insulin sensitivity from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
时间窗: 2-hour test in laboratory, 2 timepoints (baseline, 12-weeks post intervention diets)
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).
Change in glucose control (AUC) from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
时间窗: 7-day measurement during free-living, 2 timepoints (baseline, 12 weeks post intervention diets)
24-hour glucose control (24-hour AUC) will be assessed using continuous glucose monitoring for a 7-day period.
Change in blood pressure from baseline to 12 weeks post potato-rich healthy diet vs typical Western-style diet
时间窗: 20-minute measurement in the laboratory, 2 timepoints (baseline, post 12 week intervention diets)
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.
次要结局
- 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))
研究者
Dennis Cladis
Assistant Professor
Virginia Polytechnic Institute and State University