Dietary Impact on Intestinal Sulfate Metabolism | NCT05333900

NCT05333900

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Eligibility Module

Name	Affiliation	Role
Alexander Khoruts	University of Minnesota	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Arm/Group Information

ID	Title	Description
FG000	Plant-based Then Animal Based	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 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.
FG001	Animal-based Then Plant Based	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 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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Plant-based Then Animal Based	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 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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Median

Full Range

ppm hydrogen sulfide gas

Following 1-week of plant- and animal-based eating patterns

ID	Title	Description
OG000	Plant-based Diet	plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources
OG001	Animal-based Diet	animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Plant-based Diet	plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 20, 2021	Feb 23, 2022	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Mar 11, 2020	Feb 23, 2022	ICF_001.pdf

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases