Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation
- Conditions
- Prebiotics
- Interventions
- Dietary Supplement: Fiber cycles
- Registration Number
- NCT03925597
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- good general health
- Chronic inflammatory conditions
- Major organ disease
- Heavy alcohol use
- Pregnancy/lactation
- Use of medication known to affect carbohydrate or lipid metabolism
- Active eating disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan, 2- Inulin, 3- Resistant Starch, 4- Beta-Glucan ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Arabinoxylan, 3- Resistant Starch, 4- Inulin ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Resistant Starch, 3- Inulin, 4- Arabinoxylan ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Inulin, 3- Arabinoxylan, 4- Beta-Glucan ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Beta-Glucan, 3- Inulin, 4- Arabinoxylan ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Resistant Starch, 3- Arabinoxylan, 4- Inulin ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch 2- Inulin 3- Beta-Glucan 4- Arabinoxylan ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Beta-Glucan 3- Resistant Starch 4- Inulin ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Inulin 3- Beta-Glucan 4- Resistant Starch ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Arabinoxylan, 3- Inulin, 4- Resistant Starch ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Inulin, 3- Arabinoxylan, 4- Resistant Starch ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Arabinoxylan, 3- Inulin, 4- Beta-Glucan ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Arabinoxylan, 3- Beta-Glucan, 4- Inulin ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Beta-Glucan 3- Inulin 4- Resistant Starch ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Resistant Starch 3- Beta-Glucan 4- Inulin ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Arabinoxylan 2- Resistant Starch 3- Inulin 4- Beta-Glucan ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Beta-Glucan, 2- Inulin, 3- Resistant Starch, 4- Arabinoxylan ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Resistant Starch, 2- Beta-Glucan, 3- Arabinoxylan, 4- Inulin ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Resistant Starch, 3- Beta-Glucan, 4- Arabinoxylan ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Arabinoxylan, 3- Beta-Glucan, 4- Resistant Starch ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Resistant Starch, 3- Arabinoxylan, 4- Beta-Glucan ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Beta-Glucan, 3- Resistant Starch, 4- Arabinoxylan ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Beta-Glucan, 3- Arabinoxylan, 4- Resistant Starch ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan Fiber cycles Participants randomized in this arm will take the 4 fiber supplements in the following order: 1- Inulin, 2- Arabinoxylan, 3- Resistant Starch, 4- Beta-Glucan
- Primary Outcome Measures
Name Time Method Mapping of microbiota changes in response to prebiotic intervention 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 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 4 years Biological signatures will be developed from the integration of the omics data with microbial metabolite levels.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States