Trial Outcomes & Findings for Effects of Acetate and Alcohol on Brain Function (NCT NCT02542150)
NCT ID: NCT02542150
Last Updated: 2021-06-25
Results Overview
cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.
Results posted on
2021-06-25
Participant Flow
Dates: January 2016-March 2017 Target population: Healthy controls Method: Advertisements, flyers, word of mouth
Participant milestones
| Measure |
Acetate Arm
Placebo for 1 hour, then Acetate for 1 hour
IV acetate given during magnetic resonance scan.
acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
|
Alcohol Arm
Placebo for 1 hour, then Alcohol (given as a single dose of jello).
jello given before magnetic resonance scan
alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
Completed Placebo
|
12
|
12
|
|
Overall Study
Started Intervention
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Acetate and Alcohol on Brain Function
Baseline characteristics by cohort
| Measure |
Acetate Arm
n=12 Participants
Placebo for 1 hour, then Acetate for 1 hour.
IV acetate given during magnetic resonance scan
acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
|
Alcohol Arm
n=12 Participants
Placebo for 1 hour, then alcohol (given as a single dose with jello).
jello given before magnetic resonance scan
alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 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
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
31.1 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: fMRI scan will be scheduled for 1-3 weeks after enrollment. Total visit will be about 6 hrs.cerebral blood flow is measured during a functional magnetic resonance imaging (fMRI). The reported data reflects best efforts to quantify the collected image data.
Outcome measures
| Measure |
Acetate Arm
n=12 Participants
IV acetate given during magnetic resonance scan
acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
|
IV Placebo (Acetate Arm)
n=12 Participants
Placebo given before Acetate.
|
Alcohol Arm
n=12 Participants
jello shots given before magnetic resonance scan
alcohol: a "jello shot" containing alcohol, a jello shot containing no alcohol, fMRI scan.
|
Oral Placebo (Alcohol Arm)
n=12 Participants
Placebo given before Alcohol.
|
|---|---|---|---|---|
|
Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling
Right Thalamus
|
31.7 cc/100 mg/min
Standard Deviation 5.6
|
26.9 cc/100 mg/min
Standard Deviation 5.7
|
30.0 cc/100 mg/min
Standard Deviation 9.7
|
25.0 cc/100 mg/min
Standard Deviation 7.5
|
|
Change in Cerebral Blood Flow as Measured With Arterial Spin Labeling
Left Thalamus
|
32.8 cc/100 mg/min
Standard Deviation 6.8
|
27.3 cc/100 mg/min
Standard Deviation 5.6
|
29.9 cc/100 mg/min
Standard Deviation 8.9
|
24.9 cc/100 mg/min
Standard Deviation 6.7
|
Adverse Events
Acetate Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
IV Placebo (Acetate Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Placebo (Alcohol Arm)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acetate Arm
n=12 participants at risk
IV acetate given during magnetic resonance scan
acetate: acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
|
IV Placebo (Acetate Arm)
n=12 participants at risk
Placebo given before Acetate.
|
Alcohol Arm
n=12 participants at risk
jello given before magnetic resonance scan
alcohol: jello containing alcohol, jello containing no alcohol, fMRI scan.
|
Oral Placebo (Alcohol Arm)
n=12 participants at risk
Placebo given before Alcohol.
|
|---|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
8.3%
1/12 • Number of events 1 • 1 Day
|
0.00%
0/12 • 1 Day
|
0.00%
0/12 • 1 Day
|
0.00%
0/12 • 1 Day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place