Trial Outcomes & Findings for Alcohol and Neural Cardiovascular Control in Binge Drinkers (NCT NCT03567434)
NCT ID: NCT03567434
Last Updated: 2024-09-24
Results Overview
Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
1 month
Results posted on
2024-09-24
Participant Flow
Participants were recruited by word-of-mouth and advertisements. 169 participants were screened for eligibility.
38/169 participants were randomized. Of the 131 that were not randomized 100 did not meet inclusion criteria or did not consent and 31 were lost to follow-up/drop out.
Participant milestones
| Measure |
Fluid Control, Then Alcohol
Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.
Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
|
Alcohol, Then Fluid Control
Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.
Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
22
|
|
Overall Study
Completed Test 1
|
16
|
22
|
|
Overall Study
Completed Test 2
|
15
|
19
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Fluid Control, Then Alcohol
Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.
Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
|
Alcohol, Then Fluid Control
Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.
Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Alcohol and Neural Cardiovascular Control in Binge Drinkers
Baseline characteristics by cohort
| Measure |
Fluid Control, Then Alcohol
n=16 Participants
Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.
Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
|
Alcohol, Then Fluid Control
n=22 Participants
Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.
Alcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
22 participants
n=4 Participants
|
38 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 26 total participants were analyzed for primary outcome measures that completed both arms (fluid control vs. alcohol) of the study, using a randomized crossover design.
Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.
Outcome measures
| Measure |
Fluid Control
n=26 Participants
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
Alcohol
n=26 Participants
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
|---|---|---|
|
Sympathetic Nerve Activity Burst Frequency
|
18 Burst/Min
Standard Deviation 9
|
20 Burst/Min
Standard Deviation 8
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 26 total participants were analyzed for primary outcome measures that completed both arms (fluid control vs. alcohol) of the study, using a randomized crossover design.
Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity.
Outcome measures
| Measure |
Fluid Control
n=26 Participants
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
Alcohol
n=26 Participants
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
|---|---|---|
|
Sympathetic Nerve Activity Burst Incidence
|
31 burst/100 heart beats
Standard Deviation 16
|
31 burst/100 heart beats
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 1 monthPopulation: 11 total participants were analyzed for the secondary outcome measure that completed both arms of the study (fluid control vs. alcohol), with a randomized crossover design.
The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins.
Outcome measures
| Measure |
Fluid Control
n=11 Participants
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
Alcohol
n=11 Participants
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
|---|---|---|
|
Spontaneous Sympathetic Baroreflex Sensitivity
|
-2 MSNA Bursts/100 heart beats/mmHg
Standard Deviation 1
|
-2 MSNA Bursts/100 heart beats/mmHg
Standard Deviation 1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthChange in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthPolysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthThe change in muscle sympathetic nerve activity during an acute laboratory stressor.
Outcome measures
Outcome data not reported
Adverse Events
Fluid Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Alcohol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluid Control
n=38 participants at risk
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
Alcohol
n=38 participants at risk
All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/38 • On average 1 to 2 months following initial laboratory testing session
Participants were monitored for minor and serious adverse events throughout the protocol. Participants were not at risk for all-cause mortality and were not monitored for all-cause mortality. All participants were young healthy (male/female) adults and were screened for serious disorders that may predispose them towards unanticipated adverse events.
|
2.6%
1/38 • On average 1 to 2 months following initial laboratory testing session
Participants were monitored for minor and serious adverse events throughout the protocol. Participants were not at risk for all-cause mortality and were not monitored for all-cause mortality. All participants were young healthy (male/female) adults and were screened for serious disorders that may predispose them towards unanticipated adverse events.
|
|
Nervous system disorders
Presyncope in response to venipuncture
|
5.3%
2/38 • On average 1 to 2 months following initial laboratory testing session
Participants were monitored for minor and serious adverse events throughout the protocol. Participants were not at risk for all-cause mortality and were not monitored for all-cause mortality. All participants were young healthy (male/female) adults and were screened for serious disorders that may predispose them towards unanticipated adverse events.
|
0.00%
0/38 • On average 1 to 2 months following initial laboratory testing session
Participants were monitored for minor and serious adverse events throughout the protocol. Participants were not at risk for all-cause mortality and were not monitored for all-cause mortality. All participants were young healthy (male/female) adults and were screened for serious disorders that may predispose them towards unanticipated adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place