Quest to Analyze One Thousand Humans Meditating (QUANTUM)

October 31, 2024 updated by: Tobias Moeller-Bertram

Effects Of Meditation On The Gut Microbiome And Human Health and Disease

This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Meditation and other mind-body interventions (MBIs) have been shown to have a range of health benefits, including an improved stress response, a reduction in inflammatory processes, and an enhanced innate immune response. While several studies on MBIs have been carried out to assess metabolomic, transcriptomic, epigenomic, or physiological outcomes, comprehensive studies including all of these components have not been reported. In addition, most studies have been small, comprised of less than 100 research subjects.

One particular area of meditation research that remains largely unexplored is the gut. A bi-directional communication occurs between the gut and the brain, thus, the gut microbiota can influence behavior, resulting in psychosocial stress and negatively impacting the microbiome. One would predict, then, that meditation-based reductions in stress would have positive effects on gut microbial makeup. Importantly, diseased states are characterized by specific gut microbiome profiles, thus, one can use the microbiome to assay for meditation-induced changes in these states.

In this study, a comprehensive multi-omic analysis will be carried out to determine the effect of an immersive 7-day meditation experience in a retreat setting in a large 2000+ person cohort. Metagenomic analysis will be performed on the gut microbiome, including healthy and clinical populations, to assess disease-specific improvements (Phase 1). In addition, Garmin wearable technology will be used to collect biometric health data, including heart rate, sleep, stress, and activity, for up to 10 months after the meditation retreat (Phase 1). In Phase 2 of this study, the biological analyses will be expanded to include blood and urine. Taken together, these data will be coupled with self-report surveys of physical and emotional health and integrated into a machine-learning platform to assess microbiome shifts tied with epigenetics, proteomics, metabolomics, transformational language, and improvements in health.

The advanced week-long meditation retreat will include approximately 25 hours of instruction and 35 hours of meditation. The meditations will include elements of focused attention, non-dual awareness, and loving kindness compassion techniques. While these meditations are unique to this meditation teacher, they are centered around Kundalini and Vipassana techniques. The meditations will be carried out seated, standing, lying down, and walking. The retreat setting allows for controlling many variables, including sleep schedule, meditation schedule, and diet.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palm Desert, California, United States, 92260
        • VitaMed Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All study participants are registered for the advanced meditation retreat.

Description

Inclusion Criteria:

  1. Must be at 21 years of age or older
  2. Must speak English
  3. Must be a registered attendee of the advanced 7-Day meditation retreat
  4. Must be willing to wear a Garmin device for the entire retreat
  5. Must complete the research consent to participate in the study
  6. 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 7-Day meditation retreat
  4. Not willing to wear a Garmin device for the entire meditation retreat
  5. Did not complete the research consent
  6. Not willing or able to complete all self-report surveys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Meditation in an Advanced Retreat Setting on Heart Rate Variability in a Global Population
Time Frame: 4 years
In Phases 1, 2, and 3 of this study, heart rate data will be collected using a Garmin wrist device at the beginning of the meditation retreat and continuously for up to ten months after the retreat. Beat-to-beat interval data will be used to calculate heart rate variability. Time domain measures will include the mean of R-R intervals (mRR), standard deviation of all R-R intervals (SDRR), root mean square of successive R-R differences (RMSSD), and the percentage of R-R intervals that vary by at least 50 ms (pRR50). Frequency domain measures will include very low frequency (VLF), low frequency (LF), and high frequency (HF) measures.
4 years
Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites in a Global Population.
Time Frame: 4 years
In Phases 1, 2, and 3 of this study, metagenomic analysis will be carried out on stool samples collected before and after the retreat. This analysis will assess changes in gut microbes and metabolites as a function of multiple variables, including age and sex.
4 years
Effect of Meditation in an Advanced Retreat Setting on the Multi-omic Expression of Genes, Proteins, and Metabolites in the Blood in a Global Population
Time Frame: 4 years
In Phases 2 and 3 of this study, an integrative analysis of multi-omic assessments will be carried out in whole blood and plasma samples collected before and after the retreat. Whole blood will be analyzed for gene expression while proteomic and metabolomic analysis will be carried out in blood plasma.
4 years
Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health outcomes in a global population.
Time Frame: 4 years
In Phases 1, 2, and 3 of this study, physical and emotional states will be assessed using the Short Form (SF)-36 self-report survey instrument. This scale includes measures for the following domains: bodily pain, general health, mental health, physical functioning, role emotional, role physical, social functioning, and vitality. Data will be reported as the average percent change from baseline to follow-up for each domain. When necessary, data will be rescaled such that positive values will indicate improvement from pre- to post-retreat.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health for Multiple Disease States
Time Frame: 4 years
In Phases 1, 2, and 3 of this study, demographic data will be collected to assess the health status of each study subject including all physical and emotional conditions. Physical and emotional health will be assessed using the Short Form (SF)-36 self-report survey instrument. This scale includes measures for the following domains: bodily pain, general health, mental health, physical functioning, role emotional, role physical, social functioning, and vitality. Data will be reported as the average percent change from baseline to follow-up for each domain. When necessary, data will be rescaled such that positive values will indicate improvement from pre- to post-retreat.
4 years
Assess the Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites for Multiple Disease States
Time Frame: 4 years
In Phases 1, 2, and 3 of this study, metagenomic data generated in Primary Outcome #2 will be stratified by health condition. These data will highlight specific changes in gut microbes and metabolites resulting from the meditation retreat.
4 years
Assess the Effect of Meditation in an Advanced Retreat Setting on the Differential Expression of Genes, Proteins, and Metabolites in Blood for Multiple Disease States
Time Frame: 4 years
In Phases 2 and 3 of this study, transcriptomic, proteomic, and metabolomic data generated in Primary Outcome #3 will be stratified by health condition. These data will highlight specific changes in gene expression, protein expression, and metabolites resulting from the meditation retreat.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tobias Moeller-Bertram

Collaborators

University of California, San Diego
Metamorphosis, LLC

Investigators

  • Principal Investigator: Tobias Moeller-Bertram, MD, VitaMed Research LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2021

Primary Completion (Estimated)

March 25, 2025

Study Completion (Estimated)

March 25, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20211477A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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