Smart Underwear to Measure Diet-Induced Hydrogen Sulfide Production
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
High Cysteine Diet
Other interventionA healthy diet pattern which contains high levels of cysteine or cysteine-related compounds. The high and low cysteine diets will be designed by a research dietician to differ primarily in their concentration of cysteine while providing similar levels of calories, protein, fats, carbohydrates, fiber, and several micronutrients. No additional supplementation of cysteine will be used. Examples of high cysteine foods: chicken, eggs, lentils, yogurt, garlic, cheese, soybeans
Low Cysteine Diet
Other interventionA healthy diet pattern which contains low levels of cysteine or cysteine-related compounds. The high and low cysteine diets will be designed by a research dietician to differ primarily in their concentration of cysteine while providing similar levels of calories, protein, fats, carbohydrates, fiber, and several micronutrients. The low cysteine diet includes lower-protein food sources. Examples of low cysteine foods: rice, bread, oranges, bananas, lettuce, snow peas, peppers
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: High Cysteine DietActive comparator 1 intervention
Group B: Low Cysteine DietOther 1 intervention
Trial outcomes
Primary outcomes
1
Hydrogen sulfide (H2S)
Participants will be instructed to wear the Smart Underwear device for all waking hours during the baseline and feeding periods except for bathing and exercise. The Smart Underwear device does not need to be worn while sleeping due to the decreased frequency of flatus. Participants will be warned by the Smart Underwear device if the device is not worn for at least 12 hours per day or if the device detects that it is being worn incorrectly. Aggregate metrics from the device will be included in either the on-site or virtual discussions with staff.
Time frame
Daily for 6 days during each dietary intervention period (total of 12 days).Secondary outcomes
1
Microbiome Activity Index
A high gut microbiome activity is closely correlated with hydrogen gas production, reflected in the increase of both flatus frequency and hydrogen concentration (e.g., accumulated gas can be expelled in a few high-intensity events or through a series of smaller flatus). The investigators derived a Microbiome Activity Index which combines information on the rate of change in hydrogen and hydrogen sulfide, number of flatus events, and time between flatus events.
Time frame
Daily for 6 days during each dietary intervention period (total of 12 days).2
Gastrointestinal Microbiome
Participants will self-collect fecal samples using the OMNIgut OM-200 and OM-205 kits.100 Microbiome Sample Collection Kits. Shotgun metagenomic sequencing will be performed to measure changes in microbiome composition and diversity.
Time frame
The final day of each 6-day dietary intervention period (total of 2 days).3
Experienced Symptoms Questionnaire
Participants will complete a questionnaire about symptoms experienced while on each diet, including symptoms related to fall risk (e.g., feeling faint), food intake and output (e.g., bloating, constipation), fluid intake and output (e.g., excessive thirst), and general symptoms (e.g., fatigue or low energy). Participants will be asked to rate each listed symptom as: did not occur, mild, moderate, or severe. Score range 0-67, higher score worse symptoms.
Time frame
The final day of each 6-day dietary intervention period (total of 2 days).4
Participant Wearing Time
How long participants wear the Smart Underwear device. Participants will be instructed to wear the Smart Underwear device for all waking hours during the feeding intervention periods except during bathing and exercise. The Smart Underwear device does not need to be worn while sleeping due to the decreased frequency of flatus. The Smart Underwear device internally detects and records wear time; aggregated wear time metrics will be collected from the device at the end of each intervention period.
Time frame
Daily for 6 days during each dietary intervention period (total of 12 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Maryland, College Park
Collaborator
Source ClinicalTrials.gov