Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Endothelial Function
研究概览
简要总结
Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover clinical trial with three treatment arms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •metabolic syndrome defined by AHA/NHLBI criteria
- •nonsmoker
- •not taking any other vitamins or dietary supplements
- •able to have blood pressure measured bilaterally at the brachial artery
排除标准
- •any unstable medical condition that would limit the ability to participate fully in the trial
- •rheumatologic disease requiring regular use of NSAIDs
- •preexisting cardiovascular disease
- •diagnosed eating disorder
- •inability to complete endothelial function assessment.
- •use of insulin, glucose sensitizing medication, vasoactive medications (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), nutriceuticals, fiber supplements, and tobacco.
研究组 & 干预措施
Placebo
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
干预措施: Placebo (Dietary Supplement)
Blend 2
Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
干预措施: Blend 2 (Dietary Supplement)
Blend 1
Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
干预措施: Blend 1 (Dietary Supplement)
结局指标
主要结局
Endothelial Function
时间窗: 8-weeks
Endothelial function as flow-mediated dilatation (FMD)
次要结局
- Weight(8-weeks)
- Lipid panel(8-weeks)
- Insulin(8-weeks)