Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

NCT03925597 | Active Not Recruiting

• 2 other identifiers: 236025R01AT010232
• Study Type: interventional
• Target: 100
• 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. The open sharing of data generated by the proposed research represents a significant public resource that will support and accelerate future novel studies.

Conditions

Prebiotics

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (24)

ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin.

Dietary Supplement: Fiber cycles ARM 1

ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch.

Dietary Supplement: Fiber cycles ARM 2

ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: rabinoxylan, Resistant Starch, Beta-Glucan, Inulin.

Dietary Supplement: Fiber cycles ARM 3

ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan.

Dietary Supplement: Fiber cycles ARM 4

ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch.

Dietary Supplement: Fiber cycles ARM 5

ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan.

Dietary Supplement: Fiber cycles ARM 6

ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin.

Dietary Supplement: Fiber cycles ARM 7

ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch.

Dietary Supplement: Fiber cycles ARM 8

ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan.

Dietary Supplement: Fiber cycles ARM 9

ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin.

Dietary Supplement: Fiber cycles ARM 10

ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch.

Dietary Supplement: Fiber cycles ARM 11

ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan.

Dietary Supplement: Fiber cycles ARM 12

ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan.

Dietary Supplement: Fiber cycles ARM 13

ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan.

Dietary Supplement: Fiber cycles ARM 14

ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan.

Dietary Supplement: Fiber cycles ARM 15

ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin.

Dietary Supplement: Fiber cycles ARM 16

ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan.

Dietary Supplement: Fiber cycles ARM 17

ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin.

Dietary Supplement: Fiber cycles ARM 18

ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan.

Dietary Supplement: Fiber cycles ARM 19

ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan.

Dietary Supplement: Fiber cycles ARM 20

ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan.

Dietary Supplement: Fiber cycles ARM 21

ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch.

Dietary Supplement: Fiber cycles ARM 22

ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch.

Dietary Supplement: Fiber cycles ARM 23

ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan

EXPERIMENTAL

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. In this arm, participants will take the fiber supplements in the following order: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan.

Dietary Supplement: Fiber cycles ARM 24

Interventions

Fiber cycles ARM 1 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Arabinoxylan. On cycle 2, they will take 20g per day of Beta-Glucan. On cycle 3, they will take 20g per day of Resistant Starch. On cycle 4, they will take 20g per day of Inulin.

ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin

Fiber cycles ARM 2 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Arabinoxylan. On cycle 2, they will take 20g per day of Beta-Glucan. On cycle 3, they will take 20g per day of Inulin. On cycle 4, they will take 20g per day of Resistant Starch.

ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch

Fiber cycles ARM 3 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Arabinoxylan. On cycle 2, they will take 20g per day of Resistant Starch. On cycle 3, they will take 20g per day of Beta-Glucan. On cycle 4, they will take 20g per day of Inulin.

ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin

Fiber cycles ARM 4 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Arabinoxylan. On cycle 2, they will take 20g per day of Resistant Starch. On cycle 3, they will take 20g per day of Inulin. On cycle 4, they will take 20g per day of Beta-Glucan.

ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan

Fiber cycles ARM 5 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Arabinoxylan. On cycle 2, they will take 20g per day of Inulin. On cycle 3, they will take 20g per day of Beta-Glucan. On cycle 4, they will take 20g per day of Resistant Starch.

ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch

Fiber cycles ARM 6 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Arabinoxylan. On cycle 2, they will take 20g per day of Inulin. On cycle 3, they will take 20g per day of Resistant Starch. On cycle 4, they will take 20g per day of Beta-Glucan.

ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan

Fiber cycles ARM 7 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Beta-Glucan. On cycle 2, they will take 20g per day of Arabinoxylan. On cycle 3, they will take 20g per day of Resistant Starch. On cycle 4, they will take 20g per day of Inulin.

ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin

Fiber cycles ARM 8 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Beta-Glucan. On cycle 2, they will take 20g per day of Arabinoxylan. On cycle 3, they will take 20g per day of Inulin. On cycle 4, they will take 20g per day of Resistant Starch.

ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch

Fiber cycles ARM 9 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Beta-Glucan. On cycle 2, they will take 20g per day of Resistant Starch. On cycle 3, they will take 20g per day of Inulin. On cycle 4, they will take 20g per day of Arabinoxylan.

ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan

Fiber cycles ARM 10 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Beta-Glucan. On cycle 2, they will take 20g per day of Resistant Starch. On cycle 3, they will take 20g per day of Arabinoxylan. On cycle 4, they will take 20g per day of Inulin.

ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin

Fiber cycles ARM 11 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Beta-Glucan. On cycle 2, they will take 20g per day of Inulin. On cycle 3, they will take 20g per day of Arabinoxylan. On cycle 4, they will take 20g per day of Resistant Starch.

ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch

Fiber cycles ARM 12 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Beta-Glucan. On cycle 2, they will take 20g per day of Inulin. On cycle 3, they will take 20g per day of Resistant Starch. On cycle 4, they will take 20g per day of Arabinoxylan.

ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan

Fiber cycles ARM 13 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Resistant Starch. On cycle 2, they will take 20g per day of Inulin. On cycle 3, they will take 20g per day of Beta-Glucan. On cycle 4, they will take 20g per day of Arabinoxylan.

ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan

Fiber cycles ARM 14 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Resistant Starch. On cycle 2, they will take 20g per day of Inulin. On cycle 3, they will take 20g per day of Arabinoxylan. On cycle 4, they will take 20g per day of Beta-Glucan.

ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan

Fiber cycles ARM 15 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Resistant Starch. On cycle 2, they will take 20g per day of Arabinoxylan. On cycle 3, they will take 20g per day of Inulin. On cycle 4, they will take 20g per day of Beta-Glucan.

ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan

Fiber cycles ARM 16 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Resistant Starch. On cycle 2, they will take 20g per day of Arabinoxylan. On cycle 3, they will take 20g per day of Beta-Glucan. On cycle 4, they will take 20g per day of Inulin.

ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin

Fiber cycles ARM 17 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Resistant Starch. On cycle 2, they will take 20g per day of Beta-Glucan. On cycle 3, they will take 20g per day of Inulin. On cycle 4, they will take 20g per day of Arabinoxylan.

ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan

Fiber cycles ARM 18 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Resistant Starch. On cycle 2, they will take 20g per day of Beta-Glucan. On cycle 3, they will take 20g per day of Arabinoxylan. On cycle 4, they will take 20g per day of Inulin.

ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin

Fiber cycles ARM 19 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Inulin. On cycle 2, they will take 20g per day of Resistant Starch. On cycle 3, they will take 20g per day of Arabinoxylan. On cycle 4, they will take 20g per day of Beta-Glucan.

ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan

Fiber cycles ARM 20 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Inulin. On cycle 2, they will take 20g per day of Resistant Starch. On cycle 3, they will take 20g per day of Beta-Glucan. On cycle 4, they will take 20g per day of Arabinoxylan.

ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan

Fiber cycles ARM 21 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Inulin. On cycle 2, they will take 20g per day of Beta-Glucan. On cycle 3, they will take 20g per day of Resistant Starch. On cycle 4, they will take 20g per day of Arabinoxylan.

ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan

Fiber cycles ARM 22 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Inulin. On cycle 2, they will take 20g per day of Beta-Glucan. On cycle 3, they will take 20g per day of Arabinoxylan. On cycle 4, they will take 20g per day of Resistant Starch.

ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch

Fiber cycles ARM 23 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Inulin. On cycle 2, they will take 20g per day of Arabinoxylan. On cycle 3, they will take 20g per day of Beta-Glucan. On cycle 4, they will take 20g per day of Resistant Starch.

ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch

Fiber cycles ARM 24 DIETARY_SUPPLEMENT

Participants will complete 4 cycles. For each cycle, they will take 20g per day fiber supplement for 3 weeks, followed by a washout period of at least 6-8 weeks. On cycle 1, they will take 20g per day of Inulin. On cycle 2, they will take 20g per day of Arabinoxylan. On cycle 3, they will take 20g per day of Resistant Starch. On cycle 4, they will take 20g per day of Beta-Glucan.

ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan

Eligibility Criteria

• Age: 18 Years - 99 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:

• Chronic inflammatory conditions
• Major organ disease
• Heavy alcohol use
• Pregnancy/lactation
• Use of medication known to affect carbohydrate or lipid metabolism
• Active eating disorder

Sponsors & Collaborators

• Stanford University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Study Officials

• Michael P Snyder, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be given the unlabeled fiber supplement.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Professor of Genetics

Model Details: Participants will be randomized to the order of the fiber supplementation and they will take each fiber for three weeks. After a washout period, they will switch fibers. Blood and stool samples will be collected through the intervention and once during each washout period.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: April 24, 2019
• Study Start: January 21, 2020
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)