Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

Stanford University

Status: Active, not recruiting

Conditions: Prebiotics

Treatments: Dietary Supplement: Fiber cycles ARM 11; Dietary Supplement: Fiber cycles ARM 23; Dietary Supplement: Fiber cycles ARM 3; Dietary Supplement: Fiber cycles ARM 17; Dietary Supplement: Fiber cycles ARM 7; Dietary Supplement: Fiber cycles ARM 9; Dietary Supplement: Fiber cycles ARM 20; Dietary Supplement: Fiber cycles ARM 1; Dietary Supplement: Fiber cycles ARM 19; Dietary Supplement: Fiber cycles ARM 6; Dietary Supplement: Fiber cycles ARM 16; Dietary Supplement: Fiber cycles ARM 12; Dietary Supplement: Fiber cycles ARM 21; Dietary Supplement: Fiber cycles ARM 4; Dietary Supplement: Fiber cycles ARM 5; Dietary Supplement: Fiber cycles ARM 13; Dietary Supplement: Fiber cycles ARM 22; Dietary Supplement: Fiber cycles ARM 18; Dietary Supplement: Fiber cycles ARM 15; Dietary Supplement: Fiber cycles ARM 10; Dietary Supplement: Fiber cycles ARM 8; Dietary Supplement: Fiber cycles ARM 14; Dietary Supplement: Fiber cycles ARM 24; Dietary Supplement: Fiber cycles ARM 2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03925597

5R01AT010232 (U.S. NIH Grant/Contract)

23602

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• good general health

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 24 patient groups

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 1

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 2

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 3

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 4

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 5

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 6

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 7

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 8

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 9

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 10

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 11

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 12

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 13

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 14

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 15

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 16

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 17

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 18

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 19

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 20

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 21

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 22

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 23

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fiber cycles ARM 24