An Investigation of the Impact of Fruit on the Gut Microbiota and Its Metabolites: Connections to Human Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in composition of bacterial fecal microbiome at 8 weeks
研究概览
简要总结
The objectives of this study are to investigate the effect of fruit consumption on the gut microbiota and their collective fecal and plasma metabolomes, vascular and cardiometabolic functions, cognition, and motor control.
详细描述
The Investigators findings will provide data critical to the understanding of the effects of fruit intake on the gut microbiome and the capacity of the microbiota to biotransform nutrients contained within fruits as well as the subsequent impact on circulating status of those metabolites. Concurrently, health outcomes that may be linked to these changes including cognition, motor control, vascular function and cardiometabolic health risk markers will be assessed in healthy adults.
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women 30 to 70 years old
排除标准
- •History of:
- •stroke or myocardial infarction
- •gastrointestinal disorders
- •neurological disorders (epilepsy, multiple sclerosis, Parkinson's disease, stroke, etc)
- •known metabolic disorders (liver, renal or clinically diagnosed diabetes)
- •drug treatment for lipid reduction or hypertension,
- •psychiatric medication use
研究组 & 干预措施
Fruits
Participants will receive 2 cup eq fruits per day
干预措施: Fruit (2 cup eq) (Other)
Fruit restriction
Participants will receive 1/2 cup eq fruits per day
干预措施: Fruit restriction (1/2 cup eq) (Other)
结局指标
主要结局
Change from baseline in composition of bacterial fecal microbiome at 8 weeks
时间窗: At baseline, at 8 weeks
Bacterial fecal microbiome 16S rRNA gene amplicon libraries will be sequence using the Illumina MiSeq next generation sequencing platform.
次要结局
- Change from baseline in processing speed (cognition) at 8 weeks(At baseline, at 8 weeks)
- Change from baseline in Vascular health at 8 weeks(At baseline, at 8 weeks)
研究者
Shirin Hooshmand
Professor
San Diego State University