Dietary Impact on Intestinal Sulfate Metabolism

University of Minnesota (UMN)

Status: Completed

Conditions: Healthy Nutrition

Treatments: Behavioral: Plant-Based Diet then animal-based diet; Behavioral: Animal-based diet then plant-based diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05333900

GI-2016-25182

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Plant-based then animal based

Active Comparator group

Description:

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

Treatment:

Behavioral: Plant-Based Diet then animal-based diet

Animal-based then plant based

Active Comparator group

Description:

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

Treatment:

Behavioral: Animal-based diet then plant-based diet