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

NCT04706858 | Completed

• 1 other identifier: 1636
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prebiotics

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Comprehensive metagenome profile during prebiotic intervention

  3 years

• Comprehensive transcriptome profile during prebiotic intervention

  3 years

• Comprehensive metabolome profile during prebiotic intervention

  3 years

• Comprehensive cytokine profile during prebiotic intervention

  3 years

Interventions

Dietary fiber supplementation DIETARY_SUPPLEMENT

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good general health

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be given the unlabeled fiber supplement.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Dept. of Genetics

Model Details: Participants will be randomized to start fiber supplementation with one type of fiber for three weeks. After a washout period, they will supplement with the second type of fiber for an additional 3 weeks.The third cycle will be the same for all participants and they will supplement with a mix of 5 fibers for 3 weeks.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 13, 2021
• Study Start: October 15, 2014
• Primary Completion: August 11, 2017
• Study Completion: August 11, 2017
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)