Status:
COMPLETED
Dietary Impact on Intestinal Sulfate Metabolism
Lead Sponsor:
University of Minnesota
Conditions:
Healthy Nutrition
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05333900
Start Date
December 7 2016
End Date
March 18 2021
Last Update
December 5 2023
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455