Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

Prebiotics Clinical Trial

Official title:

Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03925597
• Other study ID #: 23602
• Secondary ID: 5R01AT010232
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Alessandra Celli, MS
• Phone: (650) 725-8491
• Email: alessandra.celli[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prebiotics

Intervention

Dietary Supplement:
• Fiber cycles
Participants will take 20g per day of each fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks before starting the next fiber supplement.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mapping of microbiota changes in response to prebiotic intervention	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.	3 years
Primary	Comprehensive phenotyping of host profile during prebiotic intervention	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.	4 years
Primary	Biological signatures identified from the integration of microbiome-host omes	Biological signatures will be developed from the integration of the omics data with microbial metabolite levels.	4 years