Walnut Consumption, Endothelial Function, and Plasma Adipokines in Subjects With Diabetes or Coronary Disease: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention)
研究概览
简要总结
This study will examine whether a twelve-week intervention with one ounce (28 g) per day of walnuts improves endothelial function measured non-invasively using finger probe (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30+ years
- •Prevalent coronary artery disease
- •Prevalent type 2 diabetes
排除标准
- •Current eating disorder
- •Pregnant or lactating women
- •Allergy to walnuts or other nuts
- •Inability to provide informed consent or blood samples
- •History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
- •Diagnosis of coronary heart disease or diabetes < 1 year prior to enrollment
- •Intention to move out of greater Boston area within one year
- •Current use of walnuts for more than 2 ounces per day
- •Bleeding disorder
- •Treatment with blood thinning drugs (i.e. warfarin, clopidogrel)
- •Major surgical operation 3 months before or after screening
- •Organ transplantation
- •Current participation in another trial or plan to do so during the study
- •Use of vasodilators such as nitroglycerin
- •Inability to give informed consent
- •Inability to travel to the study center at Brigham and Women's Hospital
结局指标
主要结局
Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention)
时间窗: 12 weeks
Reactive hyperemia index (RHI), which in part reflects vasodilator function of the small blood vessel at the fingertips is an indirect measure of endothelial function. Change in RHI between baseline and 12 weeks post intervention will be measured in each group using EndoPat2000 device. We will compare RHI change between walnut group and usual diet group.
次要结局
- Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention)(12 weeks)
研究者
Luc Djousse
Director of Research, Associate Professor of Medicine
Brigham and Women's Hospital