HealthySBTINCT02241226
Self-Directed Biological Transformation Initiative
A study testing Perfect Health Course in people with Healthy, run by University of California, San Diego at 1 site in United States.
Trial summary
It is becoming increasingly recognized in the literature that ancient practices for wellbeing, including meditation, yoga, and specific herbs, can improve health and promote longevity. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Perfect Health Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 40-80 years
Who cannot join
- Self-reported diagnosis of a major medical condition, such as cancer (including those who have received past radiation or chemotherapy treatment), heart disease, autoimmune disease, or diabetes, as these can affect the cell aging system and possibly the ability for telomerase to change in short periods
- Individuals taking antidepressant medication will be excluded since such medication appears to increase telomerase (Wolkowitz et al, 2010)
- Individuals with diagnosed PTSD will be excluded; there is evidence that those with PTSD may have lower telomere length as compared to those without PTSD (O'Donovan et al, 2011). It is currently unknown how PTSD may impact telomerase levels
- Estrogen use is excluded as it increases telomerase (Lin et al, 2011)
- Smokers will be excluded since smoking decreases telomerase. We will base smoking status on self report. If participants have not smoked regularly for the past 6 months, they will be considered a 'non-smoker
- Pregnant women are excluded since the cell aging system changes during pregnancy in ways that have not been studied
Show all 9Show fewer
- Participants with a Body Mass Index (BMI) of 35 or greater will be excluded due to differences in telomerase activity in obese women
- Potential eligible participants who are unable to secure the week off from work or other responsibilities will not be enrolled
- Known atrial fibrillation or other chronic dysrhythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
Chopra Center for Wellbeing
Carlsbad, California, 92009
About this study
It is becoming increasingly recognized in the literature that ancient practices for wellbeing, including meditation, yoga, and specific herbs, can improve health and promote longevity. While studies have documented such effects for a variety of individual practices for wellbeing, few studies have taken a more whole systems approach that is simultaneously inclusive of numerous practices. This intervention study, the "Self-Directed Biological Transformation Initiative", will examine the effects of a comprehensive whole systems approach to wellbeing on key biochemical, physiological, and psychosocial endpoints. Participants randomized to the Perfect Health program at the Chopra Center for Wellbeing will be compared to individuals not taking the program.
Read the detailed description
SPECIFIC AIMS
- To examine the effects of the Self-Directed Biological Transformation Initiative (SBTI) course participants compared to control group participants on key biochemical and physiological markers.
- To examine the effects of the SBTI course participants compared to control group participants on short- and long-term changes in heart rate variability, level of activity, and sleep quality.
- To examine the effects of the SBTI course participants as compared to control group participants on mood and wellbeing.
BACKGROUND AND SIGNIFICANCE It has long been thought that ancient practices can promote longevity and wellbeing but there is little empirical evidence and it is difficult to test this under controlled or experimental conditions. Recently, however, there have been several cellular-based markers that may index rate of biological aging. The rate of telomere shortening, as indexed by change in telomere length and telomerase activity, predicts both cellular and human longevity (Lin et al, 2012). It is related to malleable factors, lifestyle and psychological state (Puterman \& Epel, 2012). A secondary measure that shows promise of understanding rate of cellular aging is examination of gene expression, particularly genes related to aging. Preliminary evidence suggests that mind-body practices may slow the rate of cellular aging by improving the telomere/telomerase maintenance system. This has been examined in four small studies so far.
In the first study of its kind, a four month intensive lifestyle modification program, including yoga and group support was associated with an increase in telomerase in 39 men with prostate cancer (in preparation). There was no control group in this study. However, those with the greatest decreases in distressing thoughts about having cancer showed the biggest increases in telomerase activity (Ornish et al, 2008). In a second study, healthy men and women were randomized to a 3-month intensive in-residence meditation group or wait list control group. The researchers examined telomerase only post intervention and found that the meditation group had 30% higher telomerase, and further increases in wellbeing were associated with increases in telomerase (Jacobs et al, 2011). In another study with an active control group, examined 39 elderly high stress dementia caregivers. They randomized half the group to Yoga Nidra, listening to a 15 minute tape each day of Yoga Nidra, which includes instruction on breathing and hand movements and half to a control group which listened to a relaxation tape for 15 minutes each day. Eight weeks later, they found greater telomerase increases in the Yoga Nidra group, and across the sample, decreases in depressive symptoms were associated with increases in telomerase activity (Lavretsky et al, 2013).
Similar studies have reported positive effects of such practices on inflammatory profiles and gene expression (Tang, Ma et al. 2009, Bhasin, Dusek et al. 2013, Saatcioglu 2013). Another well studied parameter for practices such as meditation and yoga is heart rate variability (HRV) as it provides a broad measure of autonomic nervous system activity. Observational studies report HRV to be associated with stress in the workplace,(Jarczok, Jarczok et al. 2013) depressive and anxiety disorders (Gorman and Sloan 2000), and in individuals with chronic somatic complaints (Tak, Riese et al. 2009). Meditation and yoga interventions to improve HRV can lead to improved physiologic and clinical outcomes (Wheat and Larkin 2010, Papp, Lindfors et al. 2013). Other parameters can also be of potential benefit in evaluating an individual's overall wellbeing. For example, sleep duration and quality, as well as general activity levels can both contribute to and reflect overall wellbeing. To date, however, lack of compelling data around objective measures of wellbeing is in large part due to challenges associated with long term monitoring of monitoring of appropriate patient populations. However, recent advances in biosensor technologies have overcome this limitation and now allow for the non-obtrusive and passive monitoring of individuals for long periods of time. These new data streams of real-time physiologic data, couple with sophisticated and individualized data analytics can potentially identify novel measures of individual wellness, which will allow for the development of personalized therapeutic interventions to improve wellbeing.
Overall, while the results of many of the studies of traditional practices are compelling, in reality, and according the more whole system approaches such as Ayurveda and Chines Medicine, traditional practices are rarely practiced singularly, i.e, typically yoga asanas are practiced with meditation as well as a form of pranayama (breathing). With this consideration, few scientific studies have taken a more comprehensive "whole systems" approach that is simultaneously inclusive of numerous practices. Regarding outcomes, this study will take a systems biology approach to examining the biochemical, physiological, and psychosocial effects of the intervention. It is anticipated that the findings will demonstrate the value of taking a more inclusive and comprehensive whole systems approach to improving wellbeing and improved health.
- Conditions
- Healthy
- Being tested
- Perfect Health Course
- Keywords
- wellbeing, meditation, Ayurveda, yoga, herbs, health, longevity, individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfect Health CourseBehavioural
The Perfect Health course as taught at the Chopra Center for Wellbeing
| Study group | Role | What they receive |
|---|---|---|
| Perfect health course | Experimental | Perfect health course at the Chopra Center for Wellbeing Receives: Behavioral: Perfect Health Course |
| Resort group | No intervention | Resort group at the La Costa resort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RNA expression
Blood samples will be collected for RNA expression and assayed using standardized methodologies
Measured: Assessed pre and post 7 day intervention
Change in cytokine levels
Blood samples will be collected for inflammatory cytokine levels and determined via standardized ELISA methods
Measured: Assessed pre and post 7 day intervention
Change in telomerase activity
Blood samples will be collected for PBMC telomerase activity and assayed using standardized methodologies
Measured: Assessed pre and post 7 day intervention
Change in neurohormome levels
Blood and saliva samples will be collected for neurohormone levels and be determined via standardized ELISA methods
Measured: Assessed pre and post 7 day intervention
Secondary outcomes (1)
Change in heart rate variability
ECG activity will be obtained via continuous wearable wireless sensor
Measured: Assessed pre and post 7 day intervention and one month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Scripps Translational Science Institute, Duke University, Chopra Center for Wellbeing, Mount Sinai Hospital, New York, University of California, San Francisco
- Responsible party
- Principal investigator, Paul J. Mills, University of California, San Diego
- Investigators
- Paul J Mills, PHD, Study director, University of California, San DiegoRudolph E Tanzi, PhD, Study chair, Harvard UniversityDeepak Chopra, MD, Study chair, Chopra Center for Wellbeing & University of California, San DiegoElizabeth Blackburn, PhD, Principal investigator, University of California, San FranciscoElissa Epel, PhD, Principal investigator, University of California, San FranciscoSheila Patel, MD, Principal investigator, Chopra Center for Wellbeing & University of California, San DiegoValencia Porter, MD, Principal investigator, Chopra Center for Wellbeing & University of California, San DiegoEric Schadt, PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241226
- Sponsor's protocol ID
- SBTI
- Acronym
- SBTI
- Status last verified
- Dec 2015
- First submitted
- 9 Sep 2014
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Directed Biological Transformation Initiative
- ClinicalTrials.gov ID
- NCT02241226
- Acronym / sponsor ID
- SBTI / SBTI
- Conditions
- Healthy
- Keywords
- wellbeing, meditation, Ayurveda, yoga, herbs, health, longevity, individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Harvard University, Scripps Translational Science Institute, Duke University, Chopra Center for Wellbeing, Mount Sinai Hospital, New York, University of California, San Francisco
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is becoming increasingly recognized in the literature that ancient practices for wellbeing, including meditation, yoga, and specific herbs, can improve health and promote longevity. While studies have documented such effects for a variety of individual practices for wellbeing, few studies have taken a more whole systems approach that is simultaneously inclusive of numerous practices. This intervention study, the "Self-Directed Biological Transformation Initiative", will examine the effects of a comprehensive whole systems approach to wellbeing on key biochemical, physiological, and psychosocial endpoints. Participants randomized to the Perfect Health program at the Chopra Center for Wellbeing will be compared to individuals not taking the program.
Detailed description
SPECIFIC AIMS
- To examine the effects of the Self-Directed Biological Transformation Initiative (SBTI) course participants compared to control group participants on key biochemical and physiological markers.
- To examine the effects of the SBTI course participants compared to control group participants on short- and long-term changes in heart rate variability, level of activity, and sleep quality.
- To examine the effects of the SBTI course participants as compared to control group participants on mood and wellbeing.
BACKGROUND AND SIGNIFICANCE It has long been thought that ancient practices can promote longevity and wellbeing but there is little empirical evidence and it is difficult to test this under controlled or experimental conditions. Recently, however, there have been several cellular-based markers that may index rate of biological aging. The rate of telomere shortening, as indexed by change in telomere length and telomerase activity, predicts both cellular and human longevity (Lin et al, 2012). It is related to malleable factors, lifestyle and psychological state (Puterman \& Epel, 2012). A secondary measure that shows promise of understanding rate of cellular aging is examination of gene expression, particularly genes related to aging. Preliminary evidence suggests that mind-body practices may slow the rate of cellular aging by improving the telomere/telomerase maintenance system. This has been examined in four small studies so far.
In the first study of its kind, a four month intensive lifestyle modification program, including yoga and group support was associated with an increase in telomerase in 39 men with prostate cancer (in preparation). There was no control group in this study. However, those with the greatest decreases in distressing thoughts about having cancer showed the biggest increases in telomerase activity (Ornish et al, 2008). In a second study, healthy men and women were randomized to a 3-month intensive in-residence meditation group or wait list control group. The researchers examined telomerase only post intervention and found that the meditation group had 30% higher telomerase, and further increases in wellbeing were associated with increases in telomerase (Jacobs et al, 2011). In another study with an active control group, examined 39 elderly high stress dementia caregivers. They randomized half the group to Yoga Nidra, listening to a 15 minute tape each day of Yoga Nidra, which includes instruction on breathing and hand movements and half to a control group which listened to a relaxation tape for 15 minutes each day. Eight weeks later, they found greater telomerase increases in the Yoga Nidra group, and across the sample, decreases in depressive symptoms were associated with increases in telomerase activity (Lavretsky et al, 2013).
Similar studies have reported positive effects of such practices on inflammatory profiles and gene expression (Tang, Ma et al. 2009, Bhasin, Dusek et al. 2013, Saatcioglu 2013). Another well studied parameter for practices such as meditation and yoga is heart rate variability (HRV) as it provides a broad measure of autonomic nervous system activity. Observational studies report HRV to be associated with stress in the workplace,(Jarczok, Jarczok et al. 2013) depressive and anxiety disorders (Gorman and Sloan 2000), and in individuals with chronic somatic complaints (Tak, Riese et al. 2009). Meditation and yoga interventions to improve HRV can lead to improved physiologic and clinical outcomes (Wheat and Larkin 2010, Papp, Lindfors et al. 2013). Other parameters can also be of potential benefit in evaluating an individual's overall wellbeing. For example, sleep duration and quality, as well as general activity levels can both contribute to and reflect overall wellbeing. To date, however, lack of compelling data around objective measures of wellbeing is in large part due to challenges associated with long term monitoring of monitoring of appropriate patient populations. However, recent advances in biosensor technologies have overcome this limitation and now allow for the non-obtrusive and passive monitoring of individuals for long periods of time. These new data streams of real-time physiologic data, couple with sophisticated and individualized data analytics can potentially identify novel measures of individual wellness, which will allow for the development of personalized therapeutic interventions to improve wellbeing.
Overall, while the results of many of the studies of traditional practices are compelling, in reality, and according the more whole system approaches such as Ayurveda and Chines Medicine, traditional practices are rarely practiced singularly, i.e, typically yoga asanas are practiced with meditation as well as a form of pranayama (breathing). With this consideration, few scientific studies have taken a more comprehensive "whole systems" approach that is simultaneously inclusive of numerous practices. Regarding outcomes, this study will take a systems biology approach to examining the biochemical, physiological, and psychosocial effects of the intervention. It is anticipated that the findings will demonstrate the value of taking a more inclusive and comprehensive whole systems approach to improving wellbeing and improved health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perfect health course | Experimental | Behavioral: Perfect Health CoursePerfect health course at the Chopra Center for Wellbeing |
| Resort group | No intervention | –Resort group at the La Costa resort |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women between the ages of 40-80 years
Key exclusion criteria (9 listed)
- Self-reported diagnosis of a major medical condition, such as cancer (including those who have received past radiation or chemotherapy treatment), heart disease, autoimmune disease, or diabetes, as these can affect the cell aging system and possibly the ability for telomerase to change in short periods
- Individuals taking antidepressant medication will be excluded since such medication appears to increase telomerase (Wolkowitz et al, 2010)
- Individuals with diagnosed PTSD will be excluded; there is evidence that those with PTSD may have lower telomere length as compared to those without PTSD (O'Donovan et al, 2011). It is currently unknown how PTSD may impact telomerase levels
- Estrogen use is excluded as it increases telomerase (Lin et al, 2011)
- Smokers will be excluded since smoking decreases telomerase. We will base smoking status on self report. If participants have not smoked regularly for the past 6 months, they will be considered a 'non-smoker
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 |
|---|---|---|
| Perfect Health CourseThe Perfect Health course as taught at the Chopra Center for Wellbeing | Behavioural | Perfect health course |
Primary outcome
Change in RNA expression
Time frame: Assessed pre and post 7 day intervention
Blood samples will be collected for RNA expression and assayed using standardized methodologies
Change in cytokine levels
Time frame: Assessed pre and post 7 day intervention
Blood samples will be collected for inflammatory cytokine levels and determined via standardized ELISA methods
Change in telomerase activity
Time frame: Assessed pre and post 7 day intervention
Blood samples will be collected for PBMC telomerase activity and assayed using standardized methodologies
Change in neurohormome levels
Time frame: Assessed pre and post 7 day intervention
Blood and saliva samples will be collected for neurohormone levels and be determined via standardized ELISA methods
1 secondary outcome
Change in heart rate variability
Time frame: Assessed pre and post 7 day intervention and one month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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.
Paul J Mills, PHD study director
University of California, San Diego
Rudolph E Tanzi, PhD study chair
Harvard University
Deepak Chopra, MD study chair
Chopra Center for Wellbeing & University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perfect Health Course in people with Healthy, run by University of California, San Diego 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 1 inclusion and 9 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 16 Dec 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 RNA expression (time frame: Assessed pre and post 7 day intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2015.