Trial Outcomes & Findings for Endocannabinoid and Psychological Responses to Yoga in Healthy Adults (NCT NCT03710577)
NCT ID: NCT03710577
Last Updated: 2020-12-08
Results Overview
Plasma concentration of anandamide, one effector of the endocannabinoid system
COMPLETED
NA
12 participants
This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
2020-12-08
Participant Flow
Volunteers were recruited from students, faculty, and staff at the University of Wisconsin - Madison to participate in this study.
Volunteer eligibility was determined through a preliminary phone screen, participants were randomly assigned to receive the experimental task (Yoga) or the control task (quiet rest) first. Participants will then cross over 2-5 days after their first task to act as their own controls.
Participant milestones
| Measure |
Yoga, Then Quiet Rest
40 minutes of Vinyasa yoga Yoga: 1 session
2-5 days between sessions
40 minutes of quiet rest Quiet Rest: 1 session
|
Quiet Rest, Then Yoga
40 minutes of quiet rest Quiet Rest: 1 session
2-5 days between sessions
40 minutes of Yoga Yoga: 1 session
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
4
|
|
First Intervention
COMPLETED
|
8
|
4
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Time Between Sessions (2-5 Days)
STARTED
|
8
|
4
|
|
Time Between Sessions (2-5 Days)
COMPLETED
|
8
|
4
|
|
Time Between Sessions (2-5 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
8
|
4
|
|
Second Intervention
COMPLETED
|
8
|
4
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endocannabinoid and Psychological Responses to Yoga in Healthy Adults
Baseline characteristics by cohort
| Measure |
Yoga, the Quiet Rest
n=8 Participants
40 minutes of Vinyasa yoga Yoga: 1 session
2-5 days between sessions
40 minutes of Quiet Rest Quiet Rest: 1 session
|
Quiet Rest, Then Yoga
n=4 Participants
40 minutes of quiet rest Quiet Rest: 1 session
2-5 days between sessions
40 minutes of Yoga Yoga: 1 session
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.75 years
STANDARD_DEVIATION 6.92 • n=5 Participants
|
23 years
STANDARD_DEVIATION 3.16 • n=7 Participants
|
24.83 years
STANDARD_DEVIATION 5.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Native American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian or Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)Population: All participants for whom plasma samples were taken at baseline and post exercise
Plasma concentration of anandamide, one effector of the endocannabinoid system
Outcome measures
| Measure |
Yoga
n=9 Participants
40 minutes of Vinyasa yoga
Yoga: 1 session
|
Quiet Rest
n=8 Participants
40 minutes of quiet rest
Quiet Rest: 1 session
|
|---|---|---|
|
Change in Plasma Concentration of N-arachidonoylethanolamine
|
-.013 pmol/mL
Standard Deviation .928
|
-.655 pmol/mL
Standard Deviation .724
|
PRIMARY outcome
Timeframe: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)Population: All participants for whom plasma samples were taken at baseline and post exercise
Plasma concentration of 2-AG, one effector of the endocannabinoid system
Outcome measures
| Measure |
Yoga
n=9 Participants
40 minutes of Vinyasa yoga
Yoga: 1 session
|
Quiet Rest
n=8 Participants
40 minutes of quiet rest
Quiet Rest: 1 session
|
|---|---|---|
|
Change in Plasma Concentration of 2-Arachidonoylglycerol (2-AG)
|
.032 pmol/mL
Standard Deviation .074
|
-.008 pmol/mL
Standard Deviation .049
|
SECONDARY outcome
Timeframe: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)Population: All participants who completed the Profile of Mood States.
65-item self-reported mood questionnaire that measures mood "right now." Scores range from 0-200 with higher scores indicating higher mood disturbance.
Outcome measures
| Measure |
Yoga
n=12 Participants
40 minutes of Vinyasa yoga
Yoga: 1 session
|
Quiet Rest
n=12 Participants
40 minutes of quiet rest
Quiet Rest: 1 session
|
|---|---|---|
|
Change in Total Mood Disturbance as Measured by the Profile of Mood States
|
-9.41 score on a scale
Standard Deviation 9.12
|
-7.17 score on a scale
Standard Deviation 14.27
|
SECONDARY outcome
Timeframe: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)Population: All participants who completed the State-Trait Anxiety Inventory.
20-item self-reported anxiety questionnaire that measures anxiety "right now." Scores range from 20-80 with higher scores indicating higher anxiety.
Outcome measures
| Measure |
Yoga
n=12 Participants
40 minutes of Vinyasa yoga
Yoga: 1 session
|
Quiet Rest
n=12 Participants
40 minutes of quiet rest
Quiet Rest: 1 session
|
|---|---|---|
|
Change in State Anxiety as Measured by the State-Trait Anxiety Inventory
|
-1.58 score on a scale
Standard Deviation 10.48
|
-1.92 score on a scale
Standard Deviation 8.40
|
SECONDARY outcome
Timeframe: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)Population: All participants who completed the Short-form McGill Pain Questionnaire.
15-item self-reported pain questionnaire that measures pain "right now." Scores range from 0-45 with higher scores indicating higher pain.
Outcome measures
| Measure |
Yoga
n=12 Participants
40 minutes of Vinyasa yoga
Yoga: 1 session
|
Quiet Rest
n=12 Participants
40 minutes of quiet rest
Quiet Rest: 1 session
|
|---|---|---|
|
Change in Total Pain as Measured by the Short-form McGill Pain Questionnaire
|
-1.50 score on a scale
Standard Deviation 1.57
|
0.00 score on a scale
Standard Deviation 2.63
|
Adverse Events
Yoga
Quiet Rest
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