Dietary Impact on Intestinal Sulfate Metabolism
- Conditions
- Healthy Nutrition
- Interventions
- Behavioral: Animal-based diet then plant-based dietBehavioral: Plant-Based Diet then animal-based diet
- Registration Number
- NCT05333900
- Lead Sponsor
- University of Minnesota
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Animal-based then plant based Animal-based diet then plant-based diet plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources Plant-based then animal based Plant-Based Diet then animal-based diet plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources
- Primary Outcome Measures
Name Time Method Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production Following 1-week of plant- and animal-based eating patterns Determine the effect of short-term (1-week) plant- and animal-based eating patterns on ex vivo fecal hydrogen sulfide production in healthy human volunteers We will measure fecal hydrogen sulfide production ex vivo in ppm/g of dry weight of stool
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States