Quest to Analyze One Thousand Humans Meditating

NCT ID: NCT06583395

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-05

Study Completion Date

2025-03-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis (ALS) Angina, Stable Anxiety Asthma Atrial Fibrillation Cancer Brain Cancer, Breast Cancer Colon Cancer, Lung Cancer, Ovarian Cancer Prostate Cancer Skin Throat Cancer Lymphoma Cancer, Thyroid Cancer, Other Cerebral Palsy Chronic Fatigue Syndrome Cluster Headache Chronic Obstructive Pulmonary Disease (COPD) Chronic Kidney Diseases Crohn Disease Deafness Depression Diabetes Eczema Epilepsy Fibroids Fibromyalgia Heart Failure Hypertension Hyperthyroidism Hypothyroidism Irritable Bowel Syndrome (IBS) Infertility Lyme Disease Macular Degeneration Migraine Multiple Allergies Multiple Sclerosis Osteoarthritis Osteoporosis Ovarian Cysts Parkinson Disease Phantom Limb Pain Psoriasis Post Traumatic Stress Disorder (PTSD) Rheumatoid Arthritis Sjogrens Disease Spinal Cord Injury Spinal Stenosis Stroke Tension Headache Tinnitus Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Advanced multi-component meditation practice

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Metamorphosis, LLC

UNKNOWN

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

Tobias Moeller-Bertram

INDUSTRY

Sponsor Role lead

Responsible Party

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Tobias Moeller-Bertram

President

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tobias Moeller-Bertram, MD

Role: PRINCIPAL_INVESTIGATOR

VitaMed Research LLC

Locations

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VitaMed Research, LLC

Palm Desert, California, United States

Site Status

Countries

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United States

References

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Ohnishi J, Ayuzawa S, Nakamura S, Sakamoto S, Hori M, Sasaoka T, Takimoto-Ohnishi E, Tanatsugu M, Murakami K. Distinct transcriptional and metabolic profiles associated with empathy in Buddhist priests: a pilot study. Hum Genomics. 2017 Sep 2;11(1):21. doi: 10.1186/s40246-017-0117-3.

Reference Type BACKGROUND
PMID: 28865488 (View on PubMed)

Chiesa A, Serretti A. Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. J Altern Complement Med. 2009 May;15(5):593-600. doi: 10.1089/acm.2008.0495.

Reference Type BACKGROUND
PMID: 19432513 (View on PubMed)

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.

Reference Type BACKGROUND
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Muehsam D, Lutgendorf S, Mills PJ, Rickhi B, Chevalier G, Bat N, Chopra D, Gurfein B. The embodied mind: A review on functional genomic and neurological correlates of mind-body therapies. Neurosci Biobehav Rev. 2017 Feb;73:165-181. doi: 10.1016/j.neubiorev.2016.12.027. Epub 2016 Dec 23.

Reference Type BACKGROUND
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Kox M, van Eijk LT, Zwaag J, van den Wildenberg J, Sweep FC, van der Hoeven JG, Pickkers P. Voluntary activation of the sympathetic nervous system and attenuation of the innate immune response in humans. Proc Natl Acad Sci U S A. 2014 May 20;111(20):7379-84. doi: 10.1073/pnas.1322174111. Epub 2014 May 5.

Reference Type BACKGROUND
PMID: 24799686 (View on PubMed)

Chaix R, Fagny M, Cosin-Tomas M, Alvarez-Lopez M, Lemee L, Regnault B, Davidson RJ, Lutz A, Kaliman P. Differential DNA methylation in experienced meditators after an intensive day of mindfulness-based practice: Implications for immune-related pathways. Brain Behav Immun. 2020 Feb;84:36-44. doi: 10.1016/j.bbi.2019.11.003. Epub 2019 Nov 13.

Reference Type BACKGROUND
PMID: 31733290 (View on PubMed)

Chandran V, Bermudez ML, Koka M, Chandran B, Pawale D, Vishnubhotla R, Alankar S, Maturi R, Subramaniam B, Sadhasivam S. Large-scale genomic study reveals robust activation of the immune system following advanced Inner Engineering meditation retreat. Proc Natl Acad Sci U S A. 2021 Dec 21;118(51):e2110455118. doi: 10.1073/pnas.2110455118.

Reference Type BACKGROUND
PMID: 34907015 (View on PubMed)

Bhasin MK, Dusek JA, Chang BH, Joseph MG, Denninger JW, Fricchione GL, Benson H, Libermann TA. Relaxation response induces temporal transcriptome changes in energy metabolism, insulin secretion and inflammatory pathways. PLoS One. 2013 May 1;8(5):e62817. doi: 10.1371/journal.pone.0062817. Print 2013.

Reference Type BACKGROUND
PMID: 23650531 (View on PubMed)

Antoni MH, Lutgendorf SK, Blomberg B, Carver CS, Lechner S, Diaz A, Stagl J, Arevalo JM, Cole SW. Cognitive-behavioral stress management reverses anxiety-related leukocyte transcriptional dynamics. Biol Psychiatry. 2012 Feb 15;71(4):366-72. doi: 10.1016/j.biopsych.2011.10.007. Epub 2011 Nov 16.

Reference Type BACKGROUND
PMID: 22088795 (View on PubMed)

Black DS, Cole SW, Irwin MR, Breen E, St Cyr NM, Nazarian N, Khalsa DS, Lavretsky H. Yogic meditation reverses NF-kappaB and IRF-related transcriptome dynamics in leukocytes of family dementia caregivers in a randomized controlled trial. Psychoneuroendocrinology. 2013 Mar;38(3):348-55. doi: 10.1016/j.psyneuen.2012.06.011. Epub 2012 Jul 15.

Reference Type BACKGROUND
PMID: 22795617 (View on PubMed)

Venditti S, Verdone L, Reale A, Vetriani V, Caserta M, Zampieri M. Molecules of Silence: Effects of Meditation on Gene Expression and Epigenetics. Front Psychol. 2020 Aug 11;11:1767. doi: 10.3389/fpsyg.2020.01767. eCollection 2020.

Reference Type BACKGROUND
PMID: 32849047 (View on PubMed)

Alvarez-Lopez MJ, Conklin QA, Cosin-Tomas M, Shields GS, King BG, Zanesco AP, Kaliman P, Saron CD. Changes in the expression of inflammatory and epigenetic-modulatory genes after an intensive meditation retreat. Compr Psychoneuroendocrinol. 2022 Jun 23;11:100152. doi: 10.1016/j.cpnec.2022.100152. eCollection 2022 Aug.

Reference Type BACKGROUND
PMID: 35818436 (View on PubMed)

Househam AM, Peterson CT, Mills PJ, Chopra D. The Effects of Stress and Meditation on the Immune System, Human Microbiota, and Epigenetics. Adv Mind Body Med. 2017 Fall;31(4):10-25.

Reference Type BACKGROUND
PMID: 29306937 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20211477A

Identifier Type: -

Identifier Source: org_study_id

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