Clinical trial NCT03925597: Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation
Official title: Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prebiotics
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the order of the fiber supplementation and they will take each fiber for three weeks. After a washout period, they will switch fibers. Blood and stool samples will be collected through the intervention and once during each washout period.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

- good general health

Exclusion Criteria:

* Chronic inflammatory conditions
* Major organ disease
* Heavy alcohol use
* Pregnancy/lactation
* Use of medication known to affect carbohydrate or lipid metabolism
* Active eating disorder

Primary outcomes:
measure: Mapping of microbiota changes in response to prebiotic intervention
timeFrame: 3 years
measure: Comprehensive phenotyping of host profile during prebiotic intervention
timeFrame: 4 years
measure: Biological signatures identified from the integration of microbiome-host omes
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michael P Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
References: