- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03710577
Endocannabinoid and Psychological Responses to Yoga in Healthy Adults
November 16, 2020 updated by: University of Wisconsin, Madison
This study evaluates the acute effect of yoga on plasma levels of endocannabinoids and mood (i.e., mood disturbance, anxiety, pain) compared to one session of quiet rest.
Participants completed one session of yoga and one session of quiet rest on two separate days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53706
- University of Wisconsin-Madison Natatorium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- greater than or equal to 18 years old and < 45 years old and
- report being healthy.
Exclusion Criteria:
- Being pregnant or planning to become pregnant,
- currently smoking,
- having a history of light headedness or fainting during blood draws or physical activity,
- having a history of chest pain during physical activity,
- having a bone, joint, cardiac, or other medical condition that a doctor has said may be worsened by physical activity,
- taking medications for any chronic diseases such as high blood pressure or diabetes,
- responding 'Yes' to any of the seven questions on the Par-Q.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga
40 minutes of Vinyasa yoga
|
1 session
|
Placebo Comparator: Quiet Rest
40 minutes of quiet rest
|
1 session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plasma Concentration of N-arachidonoylethanolamine
Time Frame: 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)
|
Plasma concentration of anandamide, one effector of the endocannabinoid system
|
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)
|
Change in Plasma Concentration of 2-Arachidonoylglycerol (2-AG)
Time Frame: 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)
|
Plasma concentration of 2-AG, one effector of the endocannabinoid system
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Mood Disturbance as Measured by the Profile of Mood States
Time Frame: 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)
|
65-item self-reported mood questionnaire that measures mood "right now."
Scores range from 0-200 with higher scores indicating higher mood disturbance.
|
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)
|
Change in State Anxiety as Measured by the State-Trait Anxiety Inventory
Time Frame: 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)
|
20-item self-reported anxiety questionnaire that measures anxiety "right now."
Scores range from 20-80 with higher scores indicating higher anxiety.
|
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)
|
Change in Total Pain as Measured by the Short-form McGill Pain Questionnaire
Time Frame: 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)
|
15-item self-reported pain questionnaire that measures pain "right now."
Scores range from 0-45 with higher scores indicating higher pain.
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kelli Koltyn, PhD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2017
Primary Completion (Actual)
May 16, 2018
Study Completion (Actual)
May 16, 2018
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
October 15, 2018
First Posted (Actual)
October 18, 2018
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2017-0980
- A176000 (Other Identifier: UW Madison)
- EDUC/KINESIOLOGY/KINESIO (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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