Dietary Impact on Intestinal Sulfate Metabolism

NCT05333900 | Completed Results

• 1 other identifier: GI-2016-25182
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Nutrition

Keywords

Animal-based; Plant-based; Microbiome; Hydrogen sulfide; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Plant-based then animal based

ACTIVE COMPARATOR

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

Animal-based then plant based

ACTIVE COMPARATOR

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

Interventions

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.

Plant-based then animal based

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

Animal-based then plant based

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent
• Ambulatory and community dwelling
• Able and willing to comply with the study schedule and procedures
• years of age
• BMI between 18.5 - 40.0 kg/m2
• Omnivorous or willing to consume animal products through duration of study

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Alexander Khoruts
• Organization: University of Minnesota

khoru001@umn.edu

612-624-2101

Study Officials

• Alexander Khoruts

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 5-week crossover pilot study

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 19, 2022
• Study Start: December 7, 2016
• Primary Completion: December 31, 2020
• Study Completion: March 18, 2021
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-12

Locations

US (1)