Trial Outcomes & Findings for Dietary Impact on Intestinal Sulfate Metabolism (NCT NCT05333900)
NCT ID: NCT05333900
Last Updated: 2023-12-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Following 1-week of plant- and animal-based eating patterns
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
COVID-19 Pandemic
|
1
|
1
|
Baseline Characteristics
Dietary Impact on Intestinal Sulfate Metabolism
Baseline characteristics by cohort
| Measure |
Plant-based Then Animal Based
n=7 Participants
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.
|
Animal-based Then Plant Based
n=8 Participants
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
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following 1-week of plant- and animal-based eating patternsDetermine 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
Outcome measures
| Measure |
Plant-based Diet
n=11 Participants
plant based: diet low in sulfur-containing amino acids (Low-S diet), emphasizing plant-based foods and fat sources
|
Animal-based Diet
n=11 Participants
animal based: A diet high in sulfur-containing amino acids (High-S diet), emphasizing animal protein and fat sources
|
|---|---|---|
|
Effect of Short-term (1-week) Plant- and Animal-based Eating Patterns on Hydrogen Sulfide Production
|
69 ppm hydrogen sulfide gas
Interval 7.5 to 217.5
|
103 ppm hydrogen sulfide gas
Interval 27.7 to 286.9
|
Adverse Events
Plant-based Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Animal-based Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place