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Clinical Trials/NCT04706858
NCT04706858
Completed
Not Applicable

Integrative Personal Omics Profiling for Dynamic Molecular Phenotypes Monitoring During Fiber Supplementation

Stanford University1 site in 1 country18 target enrollmentOctober 15, 2014
ConditionsPrebiotics

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prebiotics
Sponsor
Stanford University
Enrollment
18
Locations
1
Primary Endpoint
Mapping of microbiota changes in response to prebiotic intervention
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed Description

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. 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.

Registry
clinicaltrials.gov
Start Date
October 15, 2014
End Date
August 11, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Snyder

Chair, Dept. of Genetics

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Good general health

Exclusion Criteria

  • Fasting Blood Sugar \>126 mg/dL
  • Triglycerides \>400 mg/dL
  • Uncontrolled hypertension
  • Vascular disease
  • Chronic inflammatory conditions
  • Major organ disease
  • Heavy alcohol use
  • Pregnancy/lactation
  • Prior bariatric surgery
  • Active psychiatric disease

Outcomes

Primary Outcomes

Mapping of microbiota changes in response to prebiotic intervention

Time Frame: 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.

Lipid profile changes in response to prebiotic intervention

Time Frame: 3 years

Analysis of changes in the the lipid profile of participants on the prebiotic intervention. Measured lipids in mg/dL include total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.

Secondary Outcomes

  • Comprehensive cytokine profile during prebiotic intervention(3 years)
  • Comprehensive transcriptome profile during prebiotic intervention(3 years)
  • Comprehensive metabolome profile during prebiotic intervention(3 years)
  • Comprehensive metagenome profile during prebiotic intervention(3 years)

Study Sites (1)

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