AzTrials
AzTrials

HealthySBTINCT02241226

Self-Directed Biological Transformation Initiative

A study testing Perfect Health Course in people with Healthy, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Perfect Health Course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteUnited States
Study dates
Sep 2014to Feb 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Chopra Center for Wellbeing

    Carlsbad, California, 92009

Other trials in United States

About this study

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.

Read the 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
Being tested
Perfect Health Course
Keywords
wellbeing, meditation, Ayurveda, yoga, herbs, health, longevity, individuals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perfect Health CourseBehavioural

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

Study groups in NCT02241226
Study groupRoleWhat they receive
Perfect health courseExperimentalPerfect health course at the Chopra Center for Wellbeing
Receives: Behavioral: Perfect Health Course
Resort groupNo interventionResort group at the La Costa resort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in RNA expression

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

    Measured: Assessed pre and post 7 day intervention

  2. Change in cytokine levels

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

    Measured: Assessed pre and post 7 day intervention

  3. Change in telomerase activity

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

    Measured: Assessed pre and post 7 day intervention

  4. Change in neurohormome levels

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

    Measured: Assessed pre and post 7 day intervention

Secondary outcomes (1)
  1. Change in heart rate variability

    ECG activity will be obtained via continuous wearable wireless sensor

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02241226
Sponsor's protocol ID
SBTI
Acronym
SBTI
Status last verified
Dec 2015
First submitted
9 Sep 2014
Last updated
16 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Perfect Health Course in people with Healthy, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in RNA expression (time frame: Assessed pre and post 7 day intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in