Microbiome Individuality and Stability Over Time

NCT04740684 | Completed

• 1 other identifier: 44718
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Microbial derived uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) are present in blood and excreted into the urine. Uremic solutes have high inter-individual variability of unclear etiology, that the investigators hypothesize is due to intestinal microbiome variation and/or dietary variation between people. In this study, the investigators will collect baseline samples on participant's habitual diet. The investigators will then administer a homogenous diet to all participants for 7 days and examine levels of uremic solutes in the urine via 24-hour urine collection during this period. In parallel, the investigators will monitor microbiome composition. The investigators predict that during the period subjects are consuming the same, homogenous diet, their excretion of uremic solutes (p-cresol sulfate, indoxyl sulfate, and phenylacetylglutamine) into the urine will have less inter-individual variation.

Conditions

Diet

Outcome Measures

Primary Outcomes (1)

• Uremic solute variability

  25% reduction of the coefficient of variation of 24hr urinary excretion of at least 1 of 3 uremic solutes (p-cresol sulfate, indoxyl sulfate or phenylacetylglutamine) measured in mg/day/1.73 during the homogenous diet period as compared to the baseline/habitual diet period.

  2 years

Interventions

Standardized diet OTHER

Standardized diet is prepared in a commercial kitchen and packaged in single serve portions to provide to participants to consume for 7 days

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals

You may not qualify if:

• pregnancy
• diabetes
• gastrointestinal disease
• use of medications thought by the investigators to have a significant effect on the microbiome

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nephrology

Model Details: All participants will consume the exact same diet for one week. Samples will be collected before, during and after the intervention.

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: August 6, 2018
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

US (1)