Integrative Personal Omics Profiling for Dynamic Molecular Phenotypes Monitoring During Fiber Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Mapping of microbiota changes in response to prebiotic intervention
研究概览
简要总结
The investigators propose a comprehensive, multiomic study that will integrate longitudinal data associating changes in specific gut bacteria and host in response to prebiotic fiber supplementation. These data will guide the development of an integrative biological signature relating bacterial-derived metabolites with biological outcome in the host.
详细描述
With this study, the investigators propose to assemble a cohort of healthy individuals that will receive prebiotic supplementation, during comprehensive, longitudinal characterization of the microbiota and host changes with clinical markers and multiple omics assays. These multiomic data will then be integrated, generating unique biological signatures that define the role that microbial metabolites from specific bacteria play in host biological activity. Through this study the investigators expect to gain a detailed and clear understanding of the physiological changes, at the mechanistic level, that occur in the microbiome and host in response to dietary supplementation with prebiotic fiber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participant will be given the unlabeled fiber supplement.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health
排除标准
- •Fasting Blood Sugar >126 mg/dL
- •Triglycerides >400 mg/dL
- •Uncontrolled hypertension
- •Vascular disease
- •Chronic inflammatory conditions
- •Major organ disease
- •Heavy alcohol use
- •Pregnancy/lactation
- •Prior bariatric surgery
- •Active psychiatric disease
- •Use of medication known to affect carbohydrate or lipid metabolism
- •Active eating disorder
结局指标
主要结局
Mapping of microbiota changes in response to prebiotic intervention
时间窗: 3 years
A detailed map of microbes and microbial gene expression changes during the intervention will be developed. Microbiota complexity in fecal samples will be determined by shotgun metagenomic sequencing. Novel microbes and gene pathways will be identified by de novo assemble of whole fecal metagenomes.
Lipid profile changes in response to prebiotic intervention
时间窗: 3 years
Analysis of changes in the the lipid profile of participants on the prebiotic intervention. Measured lipids in mg/dL include total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
次要结局
- Comprehensive cytokine profile during prebiotic intervention(3 years)
- Comprehensive transcriptome profile during prebiotic intervention(3 years)
- Comprehensive metabolome profile during prebiotic intervention(3 years)
- Comprehensive metagenome profile during prebiotic intervention(3 years)
研究者
Michael Snyder
Chair, Dept. of Genetics
Stanford University