Quest to Analyze One Thousand Humans Meditating

NCT06583395 | Enrolling By Invitation

• 1 other identifier: 20211477A
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Effect of Meditation in an Advanced Retreat Setting on Heart Rate Variability in a Global Population

  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.

  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

  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.

  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 Outcomes (3)

• Assess the Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health for Multiple Disease States

  4 years

• Assess the Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites for Multiple Disease States

  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

  4 years

Interventions

Advanced multi-component meditation practice BEHAVIORAL

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All study participants are registered for the advanced meditation retreat.

You may qualify if:

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

Sponsors & Collaborators

• Metamorphosis, LLC: collaborator
• Tobias Moeller-Bertram: lead
• University of California, San Diego: collaborator

Study Sites (1)

VitaMed Research, LLC

Palm Desert, California, 92260, United States

Location

Related Publications (13)

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  PMID: 19432513 BACKGROUND

• 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: 28670311 BACKGROUND

• 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.

  PMID: 28017838 BACKGROUND

• 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.

  PMID: 24799686 BACKGROUND

• 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.

  PMID: 34907015 BACKGROUND

• 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.

  PMID: 23650531 BACKGROUND

• 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.

  PMID: 22088795 BACKGROUND

• 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.

  PMID: 22795617 BACKGROUND

• 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.

  PMID: 28865488 BACKGROUND

• 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.

  PMID: 31733290 BACKGROUND

• 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.

  PMID: 32849047 BACKGROUND

• 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.

  PMID: 35818436 BACKGROUND

• 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.

  PMID: 29306937 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, blood plasma, buccal cells, stool, urine, tears

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Angina, Stable; Anxiety Disorders; Asthma; Atrial Fibrillation; Brain Neoplasms; Breast Neoplasms; Colonic Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Skin Neoplasms; Lymphoma; Thyroid Neoplasms; Neoplasms; Cerebral Palsy; Fatigue Syndrome, Chronic; Cluster Headache; Pulmonary Disease, Chronic Obstructive; Renal Insufficiency, Chronic; Crohn Disease; Deafness; Depression; Diabetes Mellitus; Eczema; Epilepsy; Leiomyoma; Fibromyalgia; Heart Failure; Hypertension; Hyperthyroidism; Hypothyroidism; Irritable Bowel Syndrome; Infertility; Lyme Disease; Macular Degeneration; Migraine Disorders; Multiple Sclerosis; Osteoarthritis; Osteoporosis; Ovarian Cysts; Parkinson Disease; Phantom Limb; Psoriasis; Stress Disorders, Post-Traumatic; Arthritis, Rheumatoid; Spinal Cord Injuries; Spinal Stenosis; Stroke; Tension-Type Headache; Tinnitus; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Arrhythmias, Cardiac; Pathologic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Head and Neck Neoplasms; Thyroid Diseases; Brain Damage, Chronic; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Behavioral Symptoms; Behavior; Glucose Metabolism Disorders; Dermatitis; Skin Diseases, Eczematous; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Rheumatic Diseases; Colonic Diseases, Functional; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Retinal Degeneration; Retinal Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Arthritis; Joint Diseases; Bone Diseases, Metabolic; Bone Diseases; Cysts; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Perceptual Disorders; Neurobehavioral Manifestations; Pain, Postoperative; Postoperative Complications; Skin Diseases, Papulosquamous; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Connective Tissue Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Diseases; Cerebrovascular Disorders; Colitis

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: November 29, 2023
• First Posted: September 4, 2024
• Study Start: December 5, 2021
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)