Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Self-Directed Biological Transformation Initiative (SBTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02241226
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : December 16, 2015
Sponsor:
Collaborators:
Harvard University
Scripps Translational Science Institute
Duke University
Chopra Center for Wellbeing
Mount Sinai Hospital, New York
University of California, San Francisco
Information provided by (Responsible Party):
Paul J. Mills, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE September 9, 2014
First Posted Date  ICMJE September 16, 2014
Last Update Posted Date December 16, 2015
Study Start Date  ICMJE September 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
Change in heart rate variability [ Time Frame: Assessed pre and post 7 day intervention and one month follow-up ]
ECG activity will be obtained via continuous wearable wireless sensor
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2014)
  • Change in quality of life [ Time Frame: Assessed pre and post 7 day intervention and one month follow-up ]
    A set of standardized and validated questionnaires will be administered
  • Change in gut microbiome populations [ Time Frame: Assessed pre and post 7 day intervention and one month follow-up ]
    Stool samples will be collected to determine gut microbiome using standardized methodologies
  • Change in mood [ Time Frame: Assessed pre and post 7 day intervention and one month follow-up ]
    A set of standardized and validated questionnaires will be administered
  • Change in spiritual wellbeing [ Time Frame: Assessed pre and post 7 day intervention and one month followup ]
    A set of standardized and validated questionnaires will be administered
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Self-Directed Biological Transformation Initiative
Official Title  ICMJE Self-Directed Biological Transformation Initiative
Brief 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. 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

  1. 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.
  2. 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.
  3. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Behavioral: Perfect Health Course
The Perfect Health course as taught at the Chopra Center for Wellbeing
Study Arms  ICMJE
  • Experimental: Perfect health course
    Perfect health course at the Chopra Center for Wellbeing
    Intervention: Behavioral: Perfect Health Course
  • No Intervention: Resort group
    Resort group at the La Costa resort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2015)
115
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2014)
120
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women between the ages of 40-80 years

    Exclusion Criteria:

  2. 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
  3. Individuals taking antidepressant medication will be excluded since such medication appears to increase telomerase (Wolkowitz et al, 2010)
  4. 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
  5. Estrogen use is excluded as it increases telomerase (Lin et al, 2011)
  6. 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
  7. Pregnant women are excluded since the cell aging system changes during pregnancy in ways that have not been studied
  8. Participants with a Body Mass Index (BMI) of 35 or greater will be excluded due to differences in telomerase activity in obese women
  9. Potential eligible participants who are unable to secure the week off from work or other responsibilities will not be enrolled
  10. Known atrial fibrillation or other chronic dysrhythmia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02241226
Other Study ID Numbers  ICMJE SBTI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul J. Mills, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE
  • Harvard University
  • Scripps Translational Science Institute
  • Duke University
  • Chopra Center for Wellbeing
  • Mount Sinai Hospital, New York
  • University of California, San Francisco
Investigators  ICMJE
Study Director: Paul J Mills, PHD University of California, San Diego
Study Chair: Rudolph E Tanzi, PhD Harvard University
Study Chair: Deepak Chopra, MD Chopra Center for Wellbeing & University of California, San Diego
Principal Investigator: Elizabeth Blackburn, PhD University of California, San Francisco
Principal Investigator: Elissa Epel, PhD University of California, San Francisco
Principal Investigator: Sheila Patel, MD Chopra Center for Wellbeing & University of California, San Diego
Principal Investigator: Valencia Porter, MD Chopra Center for Wellbeing & University of California, San Diego
Principal Investigator: Eric Schadt, PhD MOUNT SINAI HOSPITAL
Principal Investigator: Steven Steinhubl, MD Scripps Translational Science Institute, Scripps Research Institute
Principal Investigator: Eric Topel, MD Scripps Translational Science Institute, Scripps Research Institute
Principal Investigator: Murali Doraiswamy, MD Duke University
PRS Account University of California, San Diego
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP