HealthyNCT03710577

Endocannabinoid and Psychological Responses to Yoga in Healthy Adults

A study testing Yoga and Quiet Rest in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Yoga and Quiet Rest
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 12 Dec 2017to 16 May 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

greater than or equal to 18 years old and < 45 years old and
report being healthy.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin-Madison Natatorium
Madison, Wisconsin, 53706

Other trials in United States

About this study

Conditions: Healthy
Being tested: Yoga, Quiet Rest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

YogaBehavioural
1 session
Quiet RestBehavioural
1 session

Study groups in NCT03710577
Study group	Role	What they receive
Yoga	Experimental	40 minutes of Vinyasa yoga Receives: Behavioral: Yoga
Quiet Rest	Placebo comparator	40 minutes of quiet rest Receives: Behavioral: Quiet Rest

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Plasma Concentration of N-arachidonoylethanolamine
Plasma concentration of anandamide, one effector of the endocannabinoid system
Measured: 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)
Plasma concentration of 2-AG, one effector of the endocannabinoid system
Measured: 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 outcomes (3)

Change in Total Mood Disturbance as Measured by 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.
Measured: 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
20-item self-reported anxiety questionnaire that measures anxiety "right now." Scores range from 20-80 with higher scores indicating higher anxiety.
Measured: 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
15-item self-reported pain questionnaire that measures pain "right now." Scores range from 0-45 with higher scores indicating higher pain.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201716 May 2018

First posted18 Oct 2018
Study start12 Dec 2017
Primary completion16 May 2018
Study completion16 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03710577
Sponsor's protocol ID: 2017-0980
Other IDs: A176000, EDUC/KINESIOLOGY/KINESIO
Status last verified: Nov 2020
First submitted: 21 Jun 2018
Last updated: 8 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endocannabinoid and Psychological Responses to Yoga in Healthy Adults
ClinicalTrials.gov ID: NCT03710577
Acronym / sponsor ID: 2017-0980
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: 12 Dec 2017 (actual)
Primary completion: 16 May 2018 (actual)
Study completion: 16 May 2018 (actual)
First posted: 18 Oct 2018 (actual)
Results: Posted 26 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: The proposed study is an acute, single group, crossover pilot study where participants will complete control and experimental conditions.

Arm	Type	Receives
Yoga	Experimental	Behavioral: Yoga40 minutes of Vinyasa yoga
Quiet Rest	Placebo comparator	Behavioral: Quiet Rest40 minutes of quiet rest

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

greater than or equal to 18 years old and < 45 years old and
report being healthy.

Key exclusion criteria (7 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Yoga1 session	Behavioural	Yoga
Quiet Rest1 session	Behavioural	Quiet Rest

Primary outcome

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
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

3 secondary outcomes

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)
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)
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)

Results and safety

Results posted to the registry on 26 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Yoga, Then Quiet Rest	8	8
Quiet Rest, Then Yoga	4	4

Primary outcome: 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). Mean (Standard Deviation). Unit: pmol/mL

Measure	Yoga n = 9	Quiet Rest n = 8
Value	-.013 (.928)	-.655 (.724)

Population analysed: All participants for whom plasma samples were taken at baseline and post exercise

Primary outcome: Change in Plasma Concentration of 2-Arachidonoylglycerol (2-AG)

Measure	Yoga n = 9	Quiet Rest n = 8
Value	.032 (.074)	-.008 (.049)

Population analysed: All participants for whom plasma samples were taken at baseline and post exercise

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were monitored for adverse events while completing the research protocol on-site (i.e., 2 sessions on separate days, lasting about 1 hour each).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Yoga	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Quiet Rest	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kelli Koltyn, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Yoga and Quiet Rest in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03710577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.