Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AT010232 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
- good general health
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael P Snyder, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Participant will be given the unlabeled fiber supplement.
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|