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

Prebiotics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706858
• Other study ID #: 1636
• Status: Completed
• Phase: N/A
• Start date: October 15, 2014
• Est. completion date: August 11, 2017

Study information

• Verified date: January 2021
• Source: Stanford University
• Contact: n/a
• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 11, 2017
• Est. primary completion date: August 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

• Use of medication known to affect carbohydrate or lipid metabolism

• Active eating disorder

Related Conditions & MeSH terms

• Prebiotics

Intervention

Dietary Supplement:
• Dietary fiber supplementation
Randomization to the order of first fiber: either inulin or arabinoxylan. Third cycle will include a mix of 5 fibers: inulin, arabinoxylan, resistant starch, glucomannan, and acacia gum.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid profile changes in response to prebiotic intervention	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.	3 years
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
Secondary	Comprehensive metagenome profile during prebiotic intervention	Changes in host (human) metagenome profile during the prebiotic intervention will be determined. Stool DNA Sequences are analyzed using the Humann2 and Metaphlan pipelines to generate pathway coverage values, gene families abundances, and taxa abundances {Franzosa, 2018}. These are mapped to the Human Microbiome Project database for alignment.	3 years
Secondary	Comprehensive transcriptome profile during prebiotic intervention	Changes in host (human) transcriptome profile during the prebiotic intervention will be determined. RNA isolated from PBMC samples reads are aligned to hg38 using the program Spliced Transcripts Alignment to a Reference (STAR). Transcript abundance is calculated using RNA-Seq by Expectation Maximization (RSEM). Normalization of transcript frequency and pairwise statistics measuring differences in transcript frequency between time points are calculated using the software package for R from Bioconductor (DESeq2).	3 years
Secondary	Comprehensive metabolome profile during prebiotic intervention	Changes in host (human) metabolome profile during the prebiotic intervention will be determined. Plasma metabolites are run in mass spectrometers columns (HILIC and RPLC separation in both positive and negative ionization modes). MetID and our MS/MS data are used to identify 12740 metabolites with confidence levels ranging from 1-3, where 1 matches MS/MS, retention time and m/z from standards on our platform, 2 has MS/MS and m/z matches from a database, and 3 matches the m/z of a database.	3 years
Secondary	Comprehensive cytokine profile during prebiotic intervention	Changes in host (human) cytokine profile during the prebiotic intervention will be determined. Cytokines are profiled using a Luminex xMAP cytokine profiling system at the Stanford Human Immune Monitoring Center. This involves attaching antibodies specific to cytokines to beads using a capture molecule. The fluorescent molecules are attached to the cytokines, and fluorescence is used as the measure of cytokine abundance.	3 years