NCT00179595

Brief Summary

The purposes of this study are:

  1. 1.To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.
  2. 2.To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_2 healthy

Timeline
Completed

Started May 2002

Longer than P75 for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

9.4 years

First QC Date

September 13, 2005

Last Update Submit

February 14, 2017

Conditions

Healthy

Keywords

nitric oxide, volumetric oxygen consumption

Outcome Measures

Primary Outcomes (1)

  • To examine molecular and biochemical changes, associated with the relaxation response (RR) that can counteract the effects of stress in healthy adults.

Secondary Outcomes (1)

  • To compare genomic, molecular and biochemical parameters between healthy adults with a long term meditative practice and those with no experience in meditation.

Interventions

relaxation response- meditationBEHAVIORAL

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individual
  • age:18-49 years
  • able to read and understand English
  • able to attend al study visits
  • access to a telephone (to schedule visits)

You may not qualify if:

  • current smoking
  • asthma
  • current use of any prescription or psychoactive medications or supplements
  • either:
  • no prior experience with RR eliciting techniques
  • at least 3 years of regular RR elicitation (at least 20 min/day)
  • BMI \>30
  • exhaled nitric oxide levels \>60 ppb
  • abnormal lab values (Hct \<32,creatinine \>1.3, glucose \>200
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Study Officials

  • Herbert Benson, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

May 1, 2002

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 16, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)