N/A
N=15
Dietary Impact on Intestinal Sulfate Metabolism
Healthy Nutrition
Bottom Line
View on ClinicalTrials.gov: NCT05333900 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production — 69; 103 ppm hydrogen sulfide gas
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Plant-Based Diet then animal-based diet (Behavioral); Animal-based diet then plant-based diet (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production |
69; 103 | — |
Summary
This is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources. A 14-day washout period will follow each intervention, in which participants will eat their typical diets.
Eligibility Criteria
Inclusion Criteria
- Provide informed consent
- Ambulatory and community dwelling
- Able and willing to comply with the study schedule and procedures
- 18 - 80 years of age
- BMI between 18.5 - 40.0 kg/m2
- Omnivorous or willing to consume animal products through duration of study
Exclusion Criteria
- Antibiotic use within 3 months
- Planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics.
- Use of sulfonamides or sulfasalazine, as these sulfur-containing medications may confound results
- Use of 5-aminosalicylates (5-ASA), as they are known to inhibit sulfidogenesis
- History of anaphylactic food allergies, e.g., peanuts, seafood.
- Food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content.
- Strict vegan eating practices, with refusal to consume animal products.
- Planned use of oral probiotics while on study.
- Serious, concomitant illness that, in the opinion of the Investigator, would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation.
- Significant alcohol use, defined as > 20 g/day in females and > 30 g/day in males for a period of 3 months within one year prior to screening.
- Underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, irritable bowel syndrome, malabsorption, and celiac disease.
- History of partial or complete colectomy.
- History of malabsorptive bariatric surgery.
- Currently participating in another clinical study.
- Legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.
Data sourced from ClinicalTrials.gov (NCT05333900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.