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Self-Directed Biological Transformation Initiative (SBTI)

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Behavioral: Perfect Health Course Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-Directed Biological Transformation Initiative
Study Start Date : September 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Perfect health course
Perfect health course at the Chopra Center for Wellbeing
Behavioral: Perfect Health Course
The Perfect Health course as taught at the Chopra Center for Wellbeing

No Intervention: Resort group
Resort group at the La Costa resort



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02241226


Locations
United States, California
Chopra Center for Wellbeing
Carlsbad, California, United States, 92009
Sponsors and Collaborators
University of California, San Diego
Harvard University
Scripps Translational Science Institute
Duke University
Chopra Center for Wellbeing
Mount Sinai Hospital, New York
University of California, San Francisco
Investigators
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

Additional Information:
Responsible Party: Paul J. Mills, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02241226     History of Changes
Other Study ID Numbers: SBTI
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Keywords provided by Paul J. Mills, University of California, San Diego:
wellbeing
meditation
Ayurveda
yoga
herbs
health
longevity
individuals