Self-Directed Biological Transformation Initiative (SBTI)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Behavioral: Perfect Health Course | Not Applicable |

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
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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
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- 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
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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Men and women between the ages of 40-80 years
Exclusion Criteria:
- 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
- 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

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
United States, California | |
Chopra Center for Wellbeing | |
Carlsbad, California, United States, 92009 |
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 |
Responsible Party: | Paul J. Mills, Professor, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT02241226 |
Other Study ID Numbers: |
SBTI |
First Posted: | September 16, 2014 Key Record Dates |
Last Update Posted: | December 16, 2015 |
Last Verified: | December 2015 |
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