Smart Underwear to Measure Diet-Induced Hydrogen Sulfide Production (NCT06802276) | Clinical Trial Compass
RecruitingNot Applicable
Smart Underwear to Measure Diet-Induced Hydrogen Sulfide Production
United States25 participantsStarted 2025-05-21
Plain-language summary
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 (Hâ‚‚S) 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 Hâ‚‚S production (i.e., a high cysteine vs. low cysteine diet), in a random order.
Who can participate
Age range18 Years
SexALL
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The inclusion/exclusion criteria will identify generally healthy volunteers that are able to ingest the intervention diets. Exclusion criteria based on diseases, medications, allergies, and specific dietary requirements will minimize the risks of adverse reactions to the intervention diets.
Inclusion Criteria:
* Generally healthy volunteers defined as having no major known health conditions (e.g., diabetes, cancer, hypertension, etc.).
* Normal bowel movements, with approximately 1 bowel movement reported per day
* Willing to discuss flatus
* Ages \>18yrs
* Willing to complete the entire study protocol, i.e. eating all of the food that is provided and completing all required measurements.
Exclusion Criteria:
* 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
* Chronic medications for any of the above conditions
* Food allergy that interferes with ability to complete the study
* Food preferences, intolerance, or dietary requirements that would interfere with diet adherence
* Planned dietary changes during the study period
* Lack of appropriate food refrigeration and preparation equipment (e.g.- oven or microwave)
* Pregnancy or planned pregnancy in the next month
* Physical measurements: BMI \> 35 kg/m2
What they're measuring
1
Hydrogen sulfide (H2S)
Timeframe: Daily for 6 days during each dietary intervention period (total of 12 days).