Self-Directed Biological Transformation Initiative (SBTI)

Study Description

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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

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Study Design

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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

Arms and Interventions

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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

Outcome Measures

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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

Eligibility Criteria

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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

Contacts and Locations

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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

More Information

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Additional Information:

SBTI Link 

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
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