Clinical trial NCT04706858: Integrative Personal Omics Profiling for Dynamic Molecular Phenotypes Monitoring During Fiber Supplementation
Official title: Integrative Personal Omics Profiling for Dynamic Molecular Phenotypes Monitoring During Fiber Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prebiotics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Participants will be randomized to start fiber supplementation with one type of fiber for three weeks. After a washout period, they will supplement with the second type of fiber for an additional 3 weeks.The third cycle will be the same for all participants and they will supplement with a mix of 5 fibers for 3 weeks.
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators propose a comprehensive, multiomic study that will integrate longitudinal data associating changes in specific gut bacteria and host in response to prebiotic fiber supplementation. These data will guide the development of an integrative biological signature relating bacterial-derived metabolites with biological outcome in the host.

Detailed description: 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. 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.

Eligibility criteria: Inclusion Criteria:

* Good general health

Exclusion Criteria:

* Fasting Blood Sugar \>126 mg/dL
* Triglycerides \>400 mg/dL
* Uncontrolled hypertension
* Vascular disease
* Chronic inflammatory conditions
* Major organ disease
* Heavy alcohol use
* Pregnancy/lactation
* Prior bariatric surgery
* Active psychiatric disease
* Use of medication known to affect carbohydrate or lipid metabolism
* Active eating disorder

Primary outcomes:
measure: Lipid profile changes in response to prebiotic intervention
timeFrame: 3 years
measure: Mapping of microbiota changes in response to prebiotic intervention
timeFrame: 3 years
Secondary outcomes:
measure: Comprehensive metagenome profile during prebiotic intervention
timeFrame: 3 years
measure: Comprehensive transcriptome profile during prebiotic intervention
timeFrame: 3 years
measure: Comprehensive metabolome profile during prebiotic intervention
timeFrame: 3 years
measure: Comprehensive cytokine profile during prebiotic intervention
timeFrame: 3 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: