Evaluation of a Fasting Mimicking Diet and the Effect on Endothelial Function, Body Composition and Vascular Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from Baseline to End of Study in endothelial function
研究概览
简要总结
Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.
详细描述
Determine the effects of the FMD on cardiovascular (CV) biomarkers, coronary heart disease (CHD) risk factors (body weight, body mass index (BMI), body composition, blood pressure, serum lipid levels and dysglycemia blood measurements), noninvasive cardiovascular testing for endothelial function, arterial stiffness of large and small arteries and autonomic function testing in adult subjects over a seven-month study period.
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
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index equal to or greater than 28
- •EndoPAT® Score for endothelial function of less than or equal to 2.0 or AC 2 small resistance artery compliance by computerized arterial pulse wave analysis (CAPWA) of less than or equal to 5.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
- •Pregnant females
- •Any cancer within the past 5 years
- •Documented myocardial infarction within past 5 years
- •Documented cerebrovascular accident within past 5 years
- •Chronic steroid use (longer than 45 consecutive days
- •Type I insulin-dependent diabetes mellitus
结局指标
主要结局
Change from Baseline to End of Study in endothelial function
时间窗: 7 months
Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers
次要结局
- Change from Baseline to End of Study in cardiovascular biomarkers(7 months)