Clinical trial NCT05333900: Dietary Impact on Intestinal Sulfate Metabolism
Official title: Dietary Impact on Intestinal Sulfate Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Nutrition
Keywords: Animal-based
Plant-based
Microbiome
Hydrogen sulfide
Ulcerative colitis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 5-week crossover pilot study
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production
timeFrame: Following 1-week of plant- and animal-based eating patterns
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Alexander Khoruts
role: PRINCIPAL_INVESTIGATOR
References: