PrebioticsNCT03925597
Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation
A study testing Fiber cycles ARM 1, Fiber cycles ARM 2 and Fiber cycles ARM 3 in people with Prebiotics, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Prebiotics
- What is being tested?
- Fiber cycles ARM 1, Fiber cycles ARM 2 and Fiber cycles ARM 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- good general health
Who cannot join
- Chronic inflammatory conditions
- Major organ disease
- Heavy alcohol use
- Pregnancy/lactation
- Use of medication known to affect carbohydrate or lipid metabolism
- Active eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Prebiotics
- Being tested
- Fiber cycles ARM 1, Fiber cycles ARM 2, Fiber cycles ARM 3, Fiber cycles ARM 4, Fiber cycles ARM 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber cycles ARM 1Dietary 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.
Fiber cycles ARM 2Dietary 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.
Fiber cycles ARM 3Dietary 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.
Fiber cycles ARM 4Dietary 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.
Fiber cycles ARM 5Dietary 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.
Fiber cycles ARM 6Dietary 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.
Fiber cycles ARM 7Dietary 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.
Fiber cycles ARM 8Dietary 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.
Fiber cycles ARM 9Dietary 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.
Fiber cycles ARM 10Dietary 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.
Fiber cycles ARM 11Dietary 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.
Fiber cycles ARM 12Dietary 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.
Fiber cycles ARM 13Dietary 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.
Fiber cycles ARM 14Dietary 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.
Fiber cycles ARM 15Dietary 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.
Fiber cycles ARM 16Dietary 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.
Fiber cycles ARM 17Dietary 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.
Fiber cycles ARM 18Dietary 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.
Fiber cycles ARM 19Dietary 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.
Fiber cycles ARM 20Dietary 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.
Fiber cycles ARM 21Dietary 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.
Fiber cycles ARM 22Dietary 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.
Fiber cycles ARM 23Dietary 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.
Fiber cycles ARM 24Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Fiber cycles ARM 24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start21 Jan 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrebioticsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Michael Snyder, Stanford University
- Investigators
- Michael P Snyder, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925597
- Sponsor's protocol ID
- 23602
- Other IDs
- 5R01AT010232
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2018
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation
- ClinicalTrials.gov ID
- NCT03925597
- Acronym / sponsor ID
- 23602
- Conditions
- Prebiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 24
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin | Experimental | Dietary Supplement: Fiber cycles ARM 1Participants 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. |
| ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch | Experimental | Dietary Supplement: Fiber cycles ARM 2Participants 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. |
| ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin | Experimental | Dietary Supplement: Fiber cycles ARM 3Participants 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. |
| ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan | Experimental | Dietary Supplement: Fiber cycles ARM 4Participants 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. |
| ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch | Experimental | Dietary Supplement: Fiber cycles ARM 5Participants 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. |
| ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan | Experimental | Dietary Supplement: Fiber cycles ARM 6Participants 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. |
| ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin | Experimental | Dietary Supplement: Fiber cycles ARM 7Participants 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. |
| ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch | Experimental | Dietary Supplement: Fiber cycles ARM 8Participants 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. |
| ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan | Experimental | Dietary Supplement: Fiber cycles ARM 9Participants 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. |
| ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin | Experimental | Dietary Supplement: Fiber cycles ARM 10Participants 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. |
| ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch | Experimental | Dietary Supplement: Fiber cycles ARM 11Participants 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. |
| ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan | Experimental | Dietary Supplement: Fiber cycles ARM 12Participants 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. |
| ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan | Experimental | Dietary Supplement: Fiber cycles ARM 13Participants 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. |
| ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan | Experimental | Dietary Supplement: Fiber cycles ARM 14Participants 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. |
| ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan | Experimental | Dietary Supplement: Fiber cycles ARM 15Participants 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. |
| ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin | Experimental | Dietary Supplement: Fiber cycles ARM 16Participants 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. |
| ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan | Experimental | Dietary Supplement: Fiber cycles ARM 17Participants 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. |
| ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin | Experimental | Dietary Supplement: Fiber cycles ARM 18Participants 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. |
| ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan | Experimental | Dietary Supplement: Fiber cycles ARM 19Participants 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. |
| ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan | Experimental | Dietary Supplement: Fiber cycles ARM 20Participants 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. |
| ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan | Experimental | Dietary Supplement: Fiber cycles ARM 21Participants 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. |
| ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch | Experimental | Dietary Supplement: Fiber cycles ARM 22Participants 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. |
| ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch | Experimental | Dietary Supplement: Fiber cycles ARM 23Participants 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. |
| ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan | Experimental | Dietary Supplement: Fiber cycles ARM 24Participants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- good general health
Key exclusion criteria (6 listed)
- Chronic inflammatory conditions
- Major organ disease
- Heavy alcohol use
- Pregnancy/lactation
- Use of medication known to affect carbohydrate or lipid metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber cycles ARM 1Participants 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. | Dietary supplement | ARM 1: Arabinoxylan, Beta-Glucan, Resistant Starch, Inulin |
| Fiber cycles ARM 2Participants 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. | Dietary supplement | ARM 2: Arabinoxylan, Beta-Glucan, Inulin, Resistant Starch |
| Fiber cycles ARM 3Participants 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. | Dietary supplement | ARM 3: Arabinoxylan, Resistant Starch, Beta-Glucan, Inulin |
| Fiber cycles ARM 4Participants 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. | Dietary supplement | ARM 4: Arabinoxylan, Resistant Starch, Inulin, Beta-Glucan |
| Fiber cycles ARM 5Participants 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. | Dietary supplement | ARM 5: Arabinoxylan, Inulin, Beta-Glucan, Resistant Starch |
| Fiber cycles ARM 6Participants 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. | Dietary supplement | ARM 6: Arabinoxylan, Inulin, Resistant Starch, Beta-Glucan |
| Fiber cycles ARM 7Participants 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. | Dietary supplement | ARM 7: Beta-Glucan, Arabinoxylan, Resistant Starch, Inulin |
| Fiber cycles ARM 8Participants 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. | Dietary supplement | ARM 8: Beta-Glucan, Arabinoxylan, Inulin, Resistant Starch |
| Fiber cycles ARM 9Participants 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. | Dietary supplement | ARM 9: Beta-Glucan, Resistant Starch, Inulin, Arabinoxylan |
| Fiber cycles ARM 10Participants 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. | Dietary supplement | ARM 10: Beta-Glucan, Resistant Starch, Arabinoxylan, Inulin |
| Fiber cycles ARM 11Participants 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. | Dietary supplement | ARM 11: Beta-Glucan, Inulin, Arabinoxylan, Resistant Starch |
| Fiber cycles ARM 12Participants 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. | Dietary supplement | ARM 12: Beta-Glucan, Inulin, Resistant Starch, Arabinoxylan |
| Fiber cycles ARM 13Participants 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. | Dietary supplement | ARM 13: Resistant Starch, Inulin, Beta-Glucan, Arabinoxylan |
| Fiber cycles ARM 14Participants 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. | Dietary supplement | ARM 14: Resistant Starch, Inulin, Arabinoxylan, Beta-Glucan |
| Fiber cycles ARM 15Participants 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. | Dietary supplement | ARM 15: Resistant Starch, Arabinoxylan, Inulin, Beta-Glucan |
| Fiber cycles ARM 16Participants 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. | Dietary supplement | ARM 16: Resistant Starch, Arabinoxylan, Beta-Glucan, Inulin |
| Fiber cycles ARM 17Participants 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. | Dietary supplement | ARM 17: Resistant Starch, Beta-Glucan, Inulin, Arabinoxylan |
| Fiber cycles ARM 18Participants 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. | Dietary supplement | ARM 18: Resistant Starch, Beta-Glucan, Arabinoxylan, Inulin |
| Fiber cycles ARM 19Participants 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. | Dietary supplement | ARM 19: Inulin, Resistant Starch, Arabinoxylan, Beta-Glucan |
| Fiber cycles ARM 20Participants 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. | Dietary supplement | ARM 20: Inulin, Resistant Starch, Beta-Glucan, Arabinoxylan |
| Fiber cycles ARM 21Participants 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. | Dietary supplement | ARM 21: Inulin, Beta-Glucan, Resistant Starch, Arabinoxylan |
| Fiber cycles ARM 22Participants 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. | Dietary supplement | ARM 22: Inulin, Beta-Glucan, Arabinoxylan, Resistant Starch |
| Fiber cycles ARM 23Participants 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. | Dietary supplement | ARM 23: Inulin, Arabinoxylan, Beta-Glucan, Resistant Starch |
| Fiber cycles ARM 24Participants 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. | Dietary supplement | ARM 24: Inulin, Arabinoxylan, Resistant Starch, Beta-Glucan |
Primary outcome
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.
Comprehensive phenotyping of host profile during prebiotic intervention
Time frame: 4 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 omes
Time frame: 4 years
Biological signatures will be developed from the integration of the omics data with microbial metabolite levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Snyder, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber cycles ARM 1, Fiber cycles ARM 2 and Fiber cycles ARM 3 in people with Prebiotics, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mapping of microbiota changes in response to prebiotic intervention (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.