Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 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. The open sharing of data generated by the proposed research represents a significant public resource that will support and accelerate future novel studies.
详细描述
Phenolics-rich prebiotic fiber has been correlated with a number of positive health outcomes, however their bioavailability is typically low. A large portion the gut microbiota metabolize these fibers releasing a range of phenolic acids, which are believed to be principle bioactive components driving reduction in disease risk. Despite this, little evidence exists linking specific gut bacteria with the metabolites they produce and the downstream biological effects that these compounds exert. 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. To validate the biological function of these microbial metabolites, gnobiotic mice will be inoculated with the microbial strains identified. The newly identified metabolites will also be synthesized in vitro to demonstrate their structure, biological properties and applications. 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
- Randomized
- 干预模型
- Parallel
- 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 99 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
- •Chronic inflammatory conditions
- •Major organ disease
- •Heavy alcohol use
- •Pregnancy/lactation
- •Use of medication known to affect carbohydrate or lipid metabolism
- •Active eating disorder
研究组 & 干预措施
ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin.
干预措施: Fiber cycles ARM 1 (Dietary Supplement)
ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch.
干预措施: Fiber cycles ARM 2 (Dietary Supplement)
ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: rabinoxylan, Resistant Starch, Beta-Glucan, Inulin.
干预措施: Fiber cycles ARM 3 (Dietary Supplement)
ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan.
干预措施: Fiber cycles ARM 4 (Dietary Supplement)
ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch.
干预措施: Fiber cycles ARM 5 (Dietary Supplement)
ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan.
干预措施: Fiber cycles ARM 6 (Dietary Supplement)
ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin.
干预措施: Fiber cycles ARM 7 (Dietary Supplement)
ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch.
干预措施: Fiber cycles ARM 8 (Dietary Supplement)
ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan.
干预措施: Fiber cycles ARM 9 (Dietary Supplement)
ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin.
干预措施: Fiber cycles ARM 10 (Dietary Supplement)
ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch.
干预措施: Fiber cycles ARM 11 (Dietary Supplement)
ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan.
干预措施: Fiber cycles ARM 12 (Dietary Supplement)
ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan.
干预措施: Fiber cycles ARM 13 (Dietary Supplement)
ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan.
干预措施: Fiber cycles ARM 14 (Dietary Supplement)
ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan.
干预措施: Fiber cycles ARM 15 (Dietary Supplement)
ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin.
干预措施: Fiber cycles ARM 16 (Dietary Supplement)
ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan.
干预措施: Fiber cycles ARM 17 (Dietary Supplement)
ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin.
干预措施: Fiber cycles ARM 18 (Dietary Supplement)
ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan.
干预措施: Fiber cycles ARM 19 (Dietary Supplement)
ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan.
干预措施: Fiber cycles ARM 20 (Dietary Supplement)
ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan.
干预措施: Fiber cycles ARM 21 (Dietary Supplement)
ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch.
干预措施: Fiber cycles ARM 22 (Dietary Supplement)
ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch.
干预措施: Fiber cycles ARM 23 (Dietary Supplement)
ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan
Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan.
干预措施: Fiber cycles ARM 24 (Dietary Supplement)
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.
Comprehensive phenotyping of host profile during prebiotic intervention
时间窗: 4 years
Changes in host (human) phenotypic profile during the prebiotic intervention will be determined. Profile will include the metagenome, transcriptome, metabolome and cytokines of participants during the prebiotic intervention.
Biological signatures identified from the integration of microbiome-host omes
时间窗: 4 years
Biological signatures will be developed from the integration of the omics data with microbial metabolite levels.
次要结局
未报告次要终点
研究者
Michael Snyder
Chairman and Professor of Genetics
Stanford University