Self-Directed Biological Transformation Initiative

NCT02241226 | Completed

• 1 other identifier: SBTI
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in RNA expression

  Blood samples will be collected for RNA expression and assayed using standardized methodologies

  Assessed pre and post 7 day intervention

• Change in cytokine levels

  Blood samples will be collected for inflammatory cytokine levels and determined via standardized ELISA methods

  Assessed pre and post 7 day intervention

• Change in telomerase activity

  Blood samples will be collected for PBMC telomerase activity and assayed using standardized methodologies

  Assessed pre and post 7 day intervention

• Change in neurohormome levels

  Blood and saliva samples will be collected for neurohormone levels and be determined via standardized ELISA methods

  Assessed pre and post 7 day intervention

Secondary Outcomes (1)

• Change in heart rate variability

  Assessed pre and post 7 day intervention and one month follow-up

Other Outcomes (4)

• Change in quality of life

  Assessed pre and post 7 day intervention and one month follow-up

• Change in gut microbiome populations

  Assessed pre and post 7 day intervention and one month follow-up

• Change in mood

  Assessed pre and post 7 day intervention and one month follow-up

Study Arms (2)

Perfect health course

EXPERIMENTAL

Perfect health course at the Chopra Center for Wellbeing

Behavioral: Perfect Health Course

Resort group

NO INTERVENTION

Resort group at the La Costa resort

Interventions

Perfect Health Course BEHAVIORAL

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

Perfect health course

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 40-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Harvard University: collaborator
• Scripps Translational Science Institute: collaborator
• Duke University: collaborator
• Chopra Center for Wellbeing: collaborator
• Mount Sinai Hospital, New York: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Chopra Center for Wellbeing

Carlsbad, California, 92009, United States

Location

Study Officials

• Paul J Mills, PHD

  University of California, San Diego

  STUDY DIRECTOR

• Rudolph E Tanzi, PhD

  Harvard University

  STUDY CHAIR

• Deepak Chopra, MD

  Chopra Center for Wellbeing & University of California, San Diego

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

US (1)