The Effect of Potatoes on Markers of Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Fasting blood glucose
研究概览
简要总结
A 2-period randomized cross-over trial will be conducted to determine the effect of incorporating 1 medium size potato, compared to an isocaloric portion of refined grains, on fasting glucose levels, insulin sensitivity, blood pressure, lipids and lipoproteins, arterial stiffness, body weight, gut microbiome, and dietary intake.
详细描述
A 2-period randomized cross-over study will be conducted. Free-living subjects will be provided with a potato based side dish (equivalent to one medium sized potato) or an isocaloric refined grain based side dish every day for 4 weeks, in random order. The treatment periods will be separated by a minimum two-week break. Endpoint testing will be conducted over two days at baseline and the end of each diet period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking
- •BMI > 20 and <40 kg/m2
- •Male or female
排除标准
- •Diagnosed diabetes or fasting glucose >126 mg/dl
- •Hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg)
- •Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
- •Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
- •Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
- •Pregnancy or lactation
- •Weight loss of >=10% of body weight within the 6 months prior to enrolling in the study
- •Smoking or use of any tobacco products
结局指标
主要结局
Fasting blood glucose
时间窗: 4 weeks
次要结局
- Homeostasis Model of Assessment of Insulin Resistance(4 weeks)
- Central blood pressure(4 weeks)
- Triglycerides(4 weeks)
- Peripheral blood pressure(4 weeks)
- Total cholesterol(4 weeks)
- Pulse Wave Velocity(4 weeks)
- LDL cholesterol(4 weeks)
- Diet quality measured by the Healthy Eating Index 2010(4 weeks)
- Change in microbiome composition(Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4)
- HDL cholesterol(4 weeks)
- Augmentation index(4 weeks)
- Change in fecal short chain fatty acid levels(Week 0; Week 2 of treatment period 1; Week 4 of treatment period 1; Week 2 of treatment 2; Week 4 of treatment 4)