Trial Outcomes & Findings for Gut Butyrate and Blood Pressure in African Americans (NCT NCT04415333)
NCT ID: NCT04415333
Last Updated: 2023-10-18
Results Overview
Immediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
approximately 16 hours post enema
Results posted on
2023-10-18
Participant Flow
Participant milestones
| Measure |
Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol]
After a randomized assignment in the crossover design, participants with hypertension will come to the testing office to self-administer the first enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 ml total). After a 7-day washout period, they will return to testing office to self-administer the other enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 ml total).
|
Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol]
After a randomized assignment in the crossover design, participants with hypertension will come to the testing office to self-administer the first enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 ml total). After a 7-day washout period, they will return to the testing office to self-administer the other enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 ml total).
|
Control
African Americans with normal blood pressure (control group) will not perform self-administration of the enema. They will submit to 1 blood draw and wear the 24-hour ambulatory blood pressure monitor for 1-day.
|
|---|---|---|---|
|
First Intervention (Single 1-Day Visit)
STARTED
|
10
|
0
|
10
|
|
First Intervention (Single 1-Day Visit)
COMPLETED
|
10
|
0
|
10
|
|
First Intervention (Single 1-Day Visit)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
10
|
0
|
10
|
|
Washout (1 Week)
COMPLETED
|
10
|
0
|
10
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention (Single 1-Day Visit)
STARTED
|
10
|
0
|
10
|
|
Second Intervention (Single 1-Day Visit)
COMPLETED
|
10
|
0
|
10
|
|
Second Intervention (Single 1-Day Visit)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gut Butyrate and Blood Pressure in African Americans
Baseline characteristics by cohort
| Measure |
Sodium Butyrate [5 mmol] First, Then Sodium Butyrate [80 mmol]
n=10 Participants
After a randomized assignment in the crossover design, participants with hypertension will come to the testing office to self-administer the first enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 ml total). After a 7-day washout period, they will return to testing office to self-administer the other enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 ml total).
|
Sodium Butyrate [80 mmol] First, Then Sodium Butyrate [5 mmol]
After a randomized assignment in the crossover design, participants with hypertension will come to the testing office to self-administer the first enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 ml total). After a 7-day washout period, they will return to the testing office to self-administer the other enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 ml total).
|
Control
n=10 Participants
African Americans with normal blood pressure (control group) will not perform self-administration of the enema. They will submit to 1 blood draw and wear the 24-hour ambulatory blood pressure monitor for 1-day.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: approximately 16 hours post enemaImmediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Outcome measures
| Measure |
Sodium Butyrate [5 mmol]
n=10 Participants
Participants with hypertension self-administer an enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Sodium Butyrate [80 mmol]
n=10 Participants
Participants with hypertension self-administer an enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Control
n=10 Participants
African Americans with normal blood pressure (control group) will not perform self-administration of the enema. They will submit to 1 blood draw and wear the 24-hour ambulatory blood pressure monitor for 1-day.
|
|---|---|---|---|
|
Mean Daytime Blood Pressure
|
137.5 mmHg
Standard Deviation 13.47
|
132.9 mmHg
Standard Deviation 12.64
|
128.2 mmHg
Standard Deviation 16.31
|
PRIMARY outcome
Timeframe: approximately 8 hours post enemaImmediately following self-administration of butyrate enema, participants will be fitted with an ambulatory blood pressure monitor to be worn for 24 hours.
Outcome measures
| Measure |
Sodium Butyrate [5 mmol]
n=10 Participants
Participants with hypertension self-administer an enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Sodium Butyrate [80 mmol]
n=10 Participants
Participants with hypertension self-administer an enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Control
n=10 Participants
African Americans with normal blood pressure (control group) will not perform self-administration of the enema. They will submit to 1 blood draw and wear the 24-hour ambulatory blood pressure monitor for 1-day.
|
|---|---|---|---|
|
Mean Nighttime Blood Pressure
|
123.2 mmHg
Standard Deviation 13.5
|
116.2 mmHg
Standard Deviation 10.9
|
114.0 mmHg
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: up to 1 hour post enemaPopulation: Unable to perform venipuncture for 1 participant in the control arm. Only baseline data are reported for the control arm for reference purposes as this group did not receive the intervention. Unable to collect blood at the 60-minute time point due to consistent antecubital vein rupturing after repeated venipuncture efforts.
Measure blood butyrate concentrations before, 30 minutes post, and 60 minutes post self-administration of the butyrate enemas
Outcome measures
| Measure |
Sodium Butyrate [5 mmol]
n=10 Participants
Participants with hypertension self-administer an enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Sodium Butyrate [80 mmol]
n=10 Participants
Participants with hypertension self-administer an enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Control
n=9 Participants
African Americans with normal blood pressure (control group) will not perform self-administration of the enema. They will submit to 1 blood draw and wear the 24-hour ambulatory blood pressure monitor for 1-day.
|
|---|---|---|---|
|
Blood Butyrate Concentrations
Baseline
|
143.88 ng/mL
Standard Deviation 20.62
|
138.60 ng/mL
Standard Deviation 16.84
|
149.89 ng/mL
Standard Deviation 45.47
|
|
Blood Butyrate Concentrations
30 Minutes Post
|
138.64 ng/mL
Standard Deviation 11.29
|
151.57 ng/mL
Standard Deviation 36.12
|
—
|
SECONDARY outcome
Timeframe: up to 1 hour post enemaPopulation: Insufficient sample collected to allow for analysis for 1 participant in the sodium butyrate (80 mmol) group and unable to perform venipuncture for 1 participant in the control arm.
Blood biomarker samples were collected for the inflammatory cytokine IL-1β.
Outcome measures
| Measure |
Sodium Butyrate [5 mmol]
n=10 Participants
Participants with hypertension self-administer an enema with a concentration of 5 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Sodium Butyrate [80 mmol]
n=9 Participants
Participants with hypertension self-administer an enema with a concentration of 80 mmol sodium butyrate in a 0.9% saline solution (60 mL total).
|
Control
n=9 Participants
African Americans with normal blood pressure (control group) will not perform self-administration of the enema. They will submit to 1 blood draw and wear the 24-hour ambulatory blood pressure monitor for 1-day.
|
|---|---|---|---|
|
Interleukin-1 Beta (IL-1β) Concentration
|
NA pg/mL
Standard Deviation NA
IL-1β concentrations in every sample were below the detectable limit of 15.6 pg/mL
|
NA pg/mL
Standard Deviation NA
IL-1β concentrations in every sample were below the detectable limit of 15.6 pg/mL
|
NA pg/mL
Standard Deviation NA
IL-1β concentrations in every sample were below the detectable limit of 15.6 pg/mL
|
Adverse Events
Sodium Butyrate (5 mmol)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sodium Butyrate (80 mmol)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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