Dietary Impact on Intestinal Sulfate Metabolism

Study Overview
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Brief Summary
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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.

Official Title
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Dietary Impact on Intestinal Sulfate Metabolism

Conditions
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Healthy Nutrition

Intervention / Treatment
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* Behavioral: Plant-Based Diet then animal-based diet
* Behavioral: Animal-based diet then plant-based diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 5-week crossover pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant-based then animal based<br>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 | Behavioral: Plant-Based Diet then animal-based diet<br>* Participants started with plant based diet: high in fiber, low in animal products for 7 days, with 14 day washout period between interventions. Following that, participants were switched to animal-based diet: high in animal products, low in fiber for 7 days.<br>|
| Active Comparator: Animal-based then plant based<br>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 | Behavioral: Animal-based diet then plant-based diet<br>* Participants were started with animal-based diet: high in animal products, low in fiber for 7 days, with 14 days washout period between interventions. Following that, participants were switched to plant-based diet: high in fiber, low in animal products for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production | 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 | Following 1-week of plant- and animal-based eating patterns | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Animal-based, Plant-based, Microbiome, Hydrogen sulfide, Ulcerative colitis