Microbiome Individuality and Stability Over Time

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.

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Key information

Conditions

Diet

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

Participants will be asked to eat exactly the same meal for one week and to eat this same meal three times each day. Subjects will be allowed to eat as much of this meal as they want and to eat enough so that they do not lose weight. The food will provide a nutritionally adequate diet, designed by a registered dietitian. Participants will be asked not to eat anything else including candy, snacks, etc. and not to drink anything except water including coffee, tea, sodas, or alcoholic drinks.

Samples will be collected at 5 time points:

2 weeks prior to starting test diet, Baseline (day 1 on diet), day 4 on the diet, day 7 on the diet, 7 days after end of diet.

Samples collected include:

Blood sample Stool sample 24 hr urine collection Diet and Gastrointestinal questionnaires

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy individuals

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

Uremic solute variability

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: MISO

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Feb 5, 2021
Registry last updated: May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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