Endocannabinoid and Psychological Responses to Yoga in Healthy Adults

• ClinicalTrials.gov Identifier: NCT03710577
• Recruitment Status: Completed
• First Posted: October 18, 2018
• Results First Posted: October 26, 2020
• Last Update Posted: December 8, 2020
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Behavioral: Yoga; Behavioral: Quiet Rest	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The proposed study is an acute, single group, crossover pilot study where participants will complete control and experimental conditions.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Endocannabinoid and Psychological Responses to Yoga in Healthy Adults
• Actual Study Start Date: December 12, 2017
• Actual Primary Completion Date: May 16, 2018
• Actual Study Completion Date: May 16, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Yoga; 40 minutes of Vinyasa yoga	Behavioral: Yoga; 1 session
Placebo Comparator: Quiet Rest; 40 minutes of quiet rest	Behavioral: Quiet Rest; 1 session

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin-Madison Natatorium

Madison, Wisconsin, United States, 53706

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Kelli Koltyn, PhD; University of Wisconsin, Madison

  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:

Study Protocol and Statistical Analysis Plan  [PDF] March 6, 2018

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03710577
• Other Study ID Numbers: 2017-0980; A176000 ( Other Identifier: UW, Madison ); EDUC/KINESIOLOGY/KINESIO ( Other Identifier: UW, Madison )
• First Posted: October 18, 2018
• Results First Posted: October 26, 2020
• Last Update Posted: December 8, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No