NCT06615531

Brief Summary

This study will be focused on assessing the molecular, physiological, neuroimaging, and emotional correlates of a week-long intensive meditation retreat experience in a 20-person cohort comprised of healthy participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

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

March 23, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

September 23, 2024

Last Update Submit

October 7, 2024

Conditions

Keywords

MeditationMind-body interventionsFunctional magnetic resonance imagingQuantitative electroencephalographyEnzyme-linked immunosorbent assayMetabolomeProteomeExosomesMystical experiencesNeurite outgrowthMachine learning

Outcome Measures

Primary Outcomes (4)

  • Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat

    fMRI scans will be taken on subjects during two conditions (rest and a 15-minute meditation) before and after the week-long retreat to assess changes in brain functional connectivity associated with meditation (meditation vs rest) and resulting from the retreat (pre vs post). It is expected that whole-brain functional connectivity will become more integrated during meditation as well as after the week-long retreat. Resting state network connectivity will be assessed, and it is expected that default mode network (DMN) intra-network connectivity will decrease during meditation and more so post-retreat.

    1 week

  • Mystical Experience Questionnaire (MEQ)-30 scores before and after an intensive week-long meditation retreat

    Subjects will be given the MEQ-30 survey following a 15-minute scanner meditation before and after the retreat. An increase in MEQ-30 score is indicative of a higher shift in consciousness and presumably to a more favorable psychological state. Scores will be correlated to functional brain changes.

    1 week

  • Brain activity changes as assessed by quantitative EEQ (qEEG) before and after an intensive week-long meditation retreat.

    Brain scans will be collected by qEEG on all subjects during a 15-minute meditation before and after the retreat to assess brain complexity. It is expected that brain complexity will increase after the week-long retreat.

    1 week

  • Blood plasma proteomic and metabolomic analysis before and after an intensive week-long meditation retreat.

    An integrative analysis of proteomic and metabolomic expression in blood plasma will be carried out in samples collected before and after the retreat. The expectation is that shifts in biological processes toward an improved state of health will occur after the week-long retreat.

    1 week

Secondary Outcomes (2)

  • Heart rate variability changes during a week-long meditation retreat

    1 week

  • Effect of meditation-conditioned blood on neurite outgrowth

    1 week

Other Outcomes (1)

  • Changes in endogenous opioids after an intensive week-long meditation retreat

    1 week

Study Arms (1)

Single group study

Dr Joe Dispenza Week Long Advanced Retreat Attendees

Behavioral: Advanced multi-component meditation practice

Interventions

The study intervention is a multi-component advanced guided meditation practice that incorporates elements of focused attention, non-dual, and loving kindness and compassion meditation techniques as well as breathwork components. The practice includes sitting, lying down, standing, and walking components and is carried out at 7-day advanced meditation retreats lead by Joe Dispenza, D.C. These retreats include lecture-based instruction and up to 35 hours of meditation practice.

Single group study

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All study participants are registered for the advanced meditation retreat.

You may qualify if:

  • Must be 21 years of age or older
  • Must speak English
  • Must be a registered attendee of the advanced week-long meditation retreat
  • Must be in generally good health
  • Must agree to provide blood and buccal samples before and after the retreat
  • Must be willing to wear a Garmin device for the entire retreat
  • Must agree to fMRI scans before and after the retreat
  • Must agree to qEEG measurements before, during, and after the retreat
  • Must complete the research consent in its entirety
  • Must be willing to complete self-report surveys for physical and emotional well-being

You may not qualify if:

  • Younger than 21 years of age
  • Non-English speaking
  • Not a registered attendee of the advanced week-long meditation retreat
  • Not willing to complete the research consent
  • Has a serious health condition
  • Not willing to provide blood or buccal samples
  • Does not agree to fMRI scans
  • Not willing to wear a Garmin watch
  • Does not agree to qEEG measurements
  • Not willing or able to complete all self-report surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VitaMed Research, LLC

Palm Desert, California, 92260, United States

Location

Related Publications (10)

  • Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011.

    PMID: 21471390BACKGROUND
  • Ng TKS, Fam J, Feng L, Cheah IK, Tan CT, Nur F, Wee ST, Goh LG, Chow WL, Ho RC, Kua EH, Larbi A, Mahendran R. Mindfulness improves inflammatory biomarker levels in older adults with mild cognitive impairment: a randomized controlled trial. Transl Psychiatry. 2020 Jan 21;10(1):21. doi: 10.1038/s41398-020-0696-y.

    PMID: 32066726BACKGROUND
  • Khoury B, Knauper B, Schlosser M, Carriere K, Chiesa A. Effectiveness of traditional meditation retreats: A systematic review and meta-analysis. J Psychosom Res. 2017 Jan;92:16-25. doi: 10.1016/j.jpsychores.2016.11.006. Epub 2016 Nov 18.

    PMID: 27998508BACKGROUND
  • Oyler, D. L. et al. The Influence of Meditative Interventions on Immune Functioning: A Meta-Analysis. Mindfulness 14, 1815-1851 (2023).

    BACKGROUND
  • de Castro JM. Meditation has stronger relationships with mindfulness, kundalini, and mystical experiences than yoga or prayer. Conscious Cogn. 2015 Sep;35:115-27. doi: 10.1016/j.concog.2015.04.022. Epub 2015 May 22.

    PMID: 26002763BACKGROUND
  • Afonso RF, Kraft I, Aratanha MA, Kozasa EH. Neural correlates of meditation: a review of structural and functional MRI studies. Front Biosci (Schol Ed). 2020 Mar 1;12(1):92-115. doi: 10.2741/S542.

    PMID: 32114450BACKGROUND
  • Tang YY, Ma Y, Fan Y, Feng H, Wang J, Feng S, Lu Q, Hu B, Lin Y, Li J, Zhang Y, Wang Y, Zhou L, Fan M. Central and autonomic nervous system interaction is altered by short-term meditation. Proc Natl Acad Sci U S A. 2009 Jun 2;106(22):8865-70. doi: 10.1073/pnas.0904031106. Epub 2009 May 18.

    PMID: 19451642BACKGROUND
  • Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.

    PMID: 28670311BACKGROUND
  • Xue T, Chiao B, Xu T, Li H, Shi K, Cheng Y, Shi Y, Guo X, Tong S, Guo M, Chew SH, Ebstein RP, Cui D. The heart-brain axis: A proteomics study of meditation on the cardiovascular system of Tibetan Monks. EBioMedicine. 2022 Jun;80:104026. doi: 10.1016/j.ebiom.2022.104026. Epub 2022 May 13.

    PMID: 35576643BACKGROUND
  • Chen, W. et al. Comprehensive Metabolomic and Lipidomic Analysis Reveals Metabolic Changes After Mindfulness Training. Mindfulness 11, 1390-1400 (2020).

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Whole blood 2. Blood plasma 3. Buccal cells

Study Officials

  • Tobias Moeller-Bertram, MD

    VitaMed Research LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 26, 2024

Study Start

March 23, 2022

Primary Completion

May 6, 2023

Study Completion

May 6, 2023

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations