RECRUITING

Smart Underwear to Measure Diet-Induced Hydrogen Sulfide Production

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Conditions

Hydrogen SulfideGastrointestinal MicrobiomeH2SDietCysteineGut Microbiome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the ability of a wearable Smart Underwear prototype device to quantify diet-induced changes in gut microbial hydrogen sulfide (H₂S) production. The core design is a single-site, 2-period, crossover feeding study with 6-day diet periods and an approximately 11-day washout period. Participants are fed each of two isocaloric diets designed to contrast gut microbial H₂S production (i.e., a high cysteine vs. low cysteine diet), in a random order.

Official Title

Employing Smart Underwear to Measure Gut Microbial Hydrogen Sulfide Production

Quick Facts

Study Start:2025-03-25
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06802276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Generally healthy volunteers defined as having no major known health conditions (e.g., diabetes, cancer, hypertension, etc.).
  2. * Normal bowel movements, with approximately 1 bowel movement reported per day
  3. * Willing to discuss flatus
  4. * Ages \>18yrs
  5. * Willing to complete the entire study protocol, i.e. eating all of the food that is provided and completing all required measurements.
  1. * Self-report or other evidence of diabetes, other endocrine/metabolic abnormality, dyslipidemia, morbid obesity, severe hypertension, chronic kidney disease, liver disease, pulmonary disease, gastrointestinal, and cardiovascular diseases
  2. * Chronic medications for any of the above conditions
  3. * Food allergy that interferes with ability to complete the study
  4. * Food preferences, intolerance, or dietary requirements that would interfere with diet adherence
  5. * Planned dietary changes during the study period
  6. * Lack of appropriate food refrigeration and preparation equipment (e.g.- oven or microwave)
  7. * Pregnancy or planned pregnancy in the next month
  8. * Physical measurements: BMI \> 35 kg/m2

Contacts and Locations

Study Contact

Noel T Mueller, PhD
CONTACT
414-779-1167
noel.mueller@cuanschutz.edu

Principal Investigator

Noel T Mueller, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Andrew B Hall, PhD
PRINCIPAL_INVESTIGATOR
University of Maryland, College Park

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Noel T Mueller, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver
  • Andrew B Hall, PhD, PRINCIPAL_INVESTIGATOR, University of Maryland, College Park

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Hydrogen Sulfide
  • H2S
  • Diet
  • Cysteine
  • Gut Microbiome

Additional Relevant MeSH Terms

  • Hydrogen Sulfide
  • Gastrointestinal Microbiome