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Completed

NCT Number: NCT05333900

Dietary Impact on Intestinal Sulfate Metabolism

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plant-Based Diet then animal-based diet

Behavioral

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.

Animal-based diet then plant-based diet

Behavioral

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

Primary outcomes

  1. Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 19, 2022
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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