Clinical trial NCT06615531: Integrating Magnetic Imaging With Rich Phenotypes
Official title: Effects of Meditation on Human Well Being
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Meditation in Novice and Experienced Meditators
Keywords: Meditation
Mind-body interventions
Functional magnetic resonance imaging
Quantitative electroencephalography
Enzyme-linked immunosorbent assay
Metabolome
Proteome
Exosomes
Mystical experiences
Neurite outgrowth
Machine learning
Lead sponsor: VitaMed Research LLC
Sponsor class: INDUSTRY
Collaborators: name: Metamorphosis, LLC
name: University of California, San Diego
First posted: 2024-09-26
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants are registered for the advanced meditation retreat.

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.

Detailed description: Mind-body interventions including meditation, reconceptualization, and placebo have been shown to improve a broad range of physical and mental health outcomes in both healthy and patient populations. How and what humans think about their health has a significant and quantifiable impact.

Placebo effects, another mind-body technique that creates health improvements, have been shown to impact every major organ system. More recently, open-label placebos, placebos administered without concealment such that the subject is aware of the placebo, have been shown to be effective for a host of health conditions. Open-label placebo effects demonstrate that placebo responses are surprisingly not dependent on deception, positive expectation, or conditioning.

Meditation, yet another mind-body intervention, has been shown to reduce pain, inflammation, stress, anxiety, depression, and to improve immune function, and emotional regulation. Different meditation techniques can produce mystical-type experiences-non-ordinary perceptual, cognitive, and affective states in which the distinction between the perceiver and the perceived is transcended. The specific pathways through which meditation promotes physical and mental health are not yet well understood, but meditation-induced changes in neural activity and on the immune and autonomic nervous systems, as well as meditation-induced molecular changes in gene expression and on the proteome and metabolome suggest that these are both broad and profound.

While each of these mind-body interventions has been studied individually, the combination of meditation, reconceptualization, and open label placebo and their combined effect on health, neural activity, and molecular physiology have never been jointly studied. This exploratory observational study will employ psychometric health questionnaires; functional magnetic resonance imaging (fMRI); quantitative electroencephalography (qEEG); and blood plasma-based real time cell metabolic analysis, quantitative assessment of neurite outgrowth, and high-throughput transcriptomics, proteomics, and metabolomics to investigate the joint neural and biological effects of these three mind-body interventions in a 7-day retreat setting.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat
timeFrame: 1 week
measure: Mystical Experience Questionnaire (MEQ)-30 scores before and after an intensive week-long meditation retreat
timeFrame: 1 week
measure: Brain activity changes as assessed by quantitative EEQ (qEEG) before and after an intensive week-long meditation retreat.
timeFrame: 1 week
measure: Blood plasma proteomic and metabolomic analysis before and after an intensive week-long meditation retreat.
timeFrame: 1 week
Secondary outcomes:
measure: Heart rate variability changes during a week-long meditation retreat
timeFrame: 1 week
measure: Effect of meditation-conditioned blood on neurite outgrowth
timeFrame: 1 week
Other outcomes:
measure: Changes in endogenous opioids after an intensive week-long meditation retreat
timeFrame: 1 week
Locations:
city: Palm Desert
country: United States
facility: VitaMed Research, LLC
state: California
Study officials:
affiliation: VitaMed Research LLC
name: Tobias Moeller-Bertram, MD
role: PRINCIPAL_INVESTIGATOR
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