MedPath

Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

Not Applicable
Recruiting
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
Inclusion Criteria
  • good general health
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-GlucanFiber cyclesParticipants 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, InulinFiber cyclesParticipants 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, ArabinoxylanFiber cyclesParticipants 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-GlucanFiber cyclesParticipants 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, ArabinoxylanFiber cyclesParticipants 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, InulinFiber cyclesParticipants 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, ArabinoxylanFiber cyclesParticipants 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, InulinFiber cyclesParticipants 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 StarchFiber cyclesParticipants 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 StarchFiber cyclesParticipants 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 StarchFiber cyclesParticipants 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-GlucanFiber cyclesParticipants 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, InulinFiber cyclesParticipants 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 StarchFiber cyclesParticipants 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, InulinFiber cyclesParticipants 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-GlucanFiber cyclesParticipants 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, ArabinoxylanFiber cyclesParticipants 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, InulinFiber cyclesParticipants 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, ArabinoxylanFiber cyclesParticipants 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 StarchFiber cyclesParticipants 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-GlucanFiber cyclesParticipants 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, ArabinoxylanFiber cyclesParticipants 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 StarchFiber cyclesParticipants 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-GlucanFiber cyclesParticipants 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
NameTimeMethod
Mapping of microbiota changes in response to prebiotic intervention3 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 intervention4 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 omes4 years

Biological signatures will be developed from the integration of the omics data with microbial metabolite levels.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Stanford University

🇺🇸

Stanford, California, United States

© Copyright 2025. All Rights Reserved by MedPath