Self-Directed Biological Transformation Initiative

NCT ID: NCT02241226

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Healthy

Keywords

wellbeing; meditation; Ayurveda; yoga; herbs; health; longevity; individuals

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perfect health course

Perfect health course at the Chopra Center for Wellbeing

Group Type: EXPERIMENTAL

Perfect Health Course

Intervention Type: BEHAVIORAL

The Perfect Health course as taught at the Chopra Center for Wellbeing

Resort group

Resort group at the La Costa resort

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Perfect Health Course

The Perfect Health course as taught at the Chopra Center for Wellbeing

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard University

OTHER

Sponsor Role: collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Chopra Center for Wellbeing

UNKNOWN

Sponsor Role: collaborator

Mount Sinai Hospital, New York

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Paul J. Mills

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul J Mills, PHD

Role: STUDY_DIRECTOR

University of California, San Diego

Rudolph E Tanzi, PhD

Role: STUDY_CHAIR

Harvard University

Deepak Chopra, MD

Role: STUDY_CHAIR

Chopra Center for Wellbeing & University of California, San Diego

Elizabeth Blackburn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Elissa Epel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Sheila Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Chopra Center for Wellbeing & University of California, San Diego

Valencia Porter, MD

Role: PRINCIPAL_INVESTIGATOR

Chopra Center for Wellbeing & University of California, San Diego

Eric Schadt, PhD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Steven Steinhubl, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Science Institute, Scripps Research Institute

Eric Topel, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Science Institute, Scripps Research Institute

Murali Doraiswamy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Chopra Center for Wellbeing

Carlsbad, California, United States

Countries

United States

Other Identifiers

SBTI

Identifier Type: -

Identifier Source: org_study_id