Self-Directed Biological Transformation Initiative (SBTI) study will use latest mobile health sensors and genomic/cellular/metabolomics biomarkers

Scientists and clinicians from seven research institutions have joined together for a first of a kind clinical trial on a whole systems approach to wellbeing. Such an in-depth clinically focused study is unique because previous research studies have typically examined the beneficial effects of individual wellbeing practices – such as meditation, yoga, or specific herbal preparations – few have taken anything like a whole systems approach which simultaneously includes a number of such practices to promote improved mind-body functioning.  The Chopra Center for Wellbeing has been in the forefront of integrating whole systems approaches such as Ayurveda, meditation, yoga, massage, herbal treatments, and nutrition into programs for improving health and wellbeing.

This new study pulls these strands together in the most comprehensive manner to date.  By measuring the total effect of an intensive immersion into a whole systems program, the aim of the SBTI study is to see if the data will demonstrate a person’s connection to the healing process. The body’s healing system is still little understood as a whole, because of the complex inputs—thoughts, emotions, diet, stress, exercise, immune response, etc.—that affect whether we heal or not. The picture is further clouded when isolated findings overlap or contradict one another.

 

In the context of Ayurveda and most other traditional medicine, therapies and practices aren’t done in isolation. Instead of focusing on local symptoms, the diagnosis is systemic. Only now is Western medicine beginning to understand that a blanket condition like “stress” or “inflammation” connects many diverse disorders, including heart disease, cancer, and diabetes. A strong link has also been made to lowered immunity and aging.

 

The SBTI study will objectively examine the benefits of a whole systems approach in a controlled trial design. The resulting data will cover a broad range of biochemical, physiological, and psychosocial measurements. The intent of the study is not to examine the separate effects of the ‘active ingredients’ of the intervention, but rather assess the combined effects of the full suite of wellness practices.

 

The SBTI study will be being conducted during a weeklong intensive Ayurveda treatment program at the Chopra Center, located at the OMNI La Costa Resort in Carlsbad, CA. Potential study participants are randomized to join either the Ayurveda program or a seven-day stay at the resort without treatment, which serves as the control. Participants are evaluated four times: at home prior to arriving at the Center, immediately upon arrival, immediately following the treatment program, and one month later in a follow-up assessment. As shown in the table below, the contributing institutions are examining many crucial markers through sophisticated testing of

 

• RNA expression
• telomerase activity (linked to the aging process)
• a variety of metabolites, peptides, and neurohormones (connected to metabolism, addictions, and mood changes as well as the messaging between brain and body)
• the microbiome (the enormous population of microorganisms on the skin and in the intestinal tract, and their collective genetic material)
• circulating protease activity
• mobile cardiac functioning
• balance of the autonomic nervous system
• assessments of mental, emotional, and spiritual wellbeing.

 

It is anticipated that findings from the SBTI study will demonstrate the considerable cumulative value of taking a whole systems approach to health and wellbeing (an expectation bolstered by important studies cited below). If the results of the SBTI study are strong, it should deepen our appreciation of the potential for wellness that exists in the body-mind system. This will be a critical next step in lending empirical validation to whole systems approaches and could inspire greater dissemination and availability of such approaches into mainstream medicine, as the integrative health movement strongly advocates for.

 

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Deepak Chopra, MD, FACP, Co-Chair of SBTI Research Project, Founder of The Chopra Center for Wellbeing, and Assistant Clinical Professor of Family and Preventive Medicine, University of California, San Diego

 

Rudolph E. Tanzi, PhD, Co-Chair of SBTI Research Project, Joseph P. and Rose F. Kennedy Professor of Neurology, Director of the Genetics and Aging Research Unit and Vice-Chair of the Department of Neurology at Massachusetts General Hospital, Harvard Medical School

 

Paul J. Mills, PhD, Director of Research, The Chopra Foundation, Professor of Psychiatry, Behavioral Medicine Program, Director, Clinical Research Biomarker Laboratory, University of California, San Diego

 

Elizabeth Blackburn, PhD, Morris Herzstein Professor in Biology and Physiology, University of California, San Francisco

P. Murali Doraiswamy, M.D., Professor of Psychiatry and Member, Duke Institute for Brain Sciences and M. Arthur Moseley PhD, Director Duke University Proteomics Facility

 

Elissa Epel, PhD, Associate Professor of Psychiatry, University of California, San Francisco

 

Sheila Patel, MD, Medical Director, Chopra Center for Wellbeing, Clinical Instructor of Family and Preventive Medicine, University of California, San Diego

 

Valencia Porter, MD, Director of Integrative Medicine, Chopra Center for Wellbeing for Wellbeing, Clinical Instructor of Family and Preventive Medicine, University of California, San Diego

 

Eric Schadt, PhD, Director of the Institute for Genomics and Multiscale Biology, Chair of the Department of Genetics and Genomics Sciences, and the Jean C. and James W. Crystal Professor of Genomics, Mount Sinai Hospital

 

Steven R. Steinhubl, MD, Director of Digital Medicine and Professor, Scripps Translational Science Institute, Scripps Research Institute

 

Eric J. Topol, MD, Director, Scripps Translational Science Institute Chief Academic Officer, Professor of Genomics, Scripps Research Institute

 

*Potential conflicts of interest: One or more study investigators may have financial relationships with healthcare and/or biotechnology companies and tests.

 

Changes in emerging cardiac biomarkers after an intensive lifestyle intervention.  Chainani-Wu N, Weidner G, Purnell DM, Frenda S, Merritt-Worden T, Pischke C, Campo R, Kemp C, Kersh ES, Ornish D.  Am J Cardiol. 2011;108(4):498-507.

 

Intensive meditation training, immune cell telomerase activity, and psychological mediators.  Jacobs TL, Epel ES, Lin J, Blackburn EH, Wolkowitz OM, Bridwell DA, Zanesco AP, Aichele SR, Sahdra BK, MacLean KA, King BG, Shaver PR, Rosenberg EL,Ferrer E, Wallace BA, Saron CD. Psychoneuroendocrinology. 2011;36(5):664-81.

Collaborating Institutions and Contributions to the Self-Directed Biological Transformation Initiative (SBTI) Research Study

Institution
Harvard University Gene Lab, Boston, MA

Assessments
1. Whole genome sequencing using HiSeq at Illumina, gene expression of roughly 40,000 transcripts
2. Alzheimer’s-related amyloid beta protein species in plasma
3. Cytokine levels in plasma
4. Whole-genome epigenetic changes using Pacific Bio systems; plasma proteome

Institution
Mount Sinai Hospital, New York, NY

Assessments
1. Bioinformatics for all data generated by the Harvard Lab listed above
2. Microbiome of gut
3. Microbiome of skin
4. RNA expression

Institution
Scripps Translational Science Institute, La Jolla, CA

Assessments
1. Mobile ECG & heart rate variability monitoring
2. Physical activity / Sleep
3. Respiratory rate and depth

Institution
University of California, San Diego, La Jolla, CA

Assessments
1. Inflammation, cardiovascular disease biomarkers
2. Stress biomarkers
3. Circulating protease activity – metalloproteinases, trypsin, elastase, chymotrypsin
4. Psychosocial assessments

Institution
Duke University, Durham, NC

Assessments
1. Metabolomics
2. Mood assessments

Institution
University of California, San Francisco, San Francisco, CA

Assessments
1. Telomerase and telomere length
2. Oxidative stress
3. Mitochondrial DNA health

Institution
Chopra Center for Wellbeing, La Costa, CA & Chopra Foundation (La Costa, CA) & Fred Foundation (Hilversum, The Netherlands)

Assessments
1. Perfect Health Ayurvedic Program
2. Integrative Medical consultation
3. SBTI and onsite program support