Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06583395

Quest to Analyze One Thousand Humans Meditating

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Adnexal Diseases Amyotrophic Lateral Sclerosis Angina Pectoris Angina, Stable Anxiety Anxiety Disorders Arrhythmias, Cardiac Arthritis Arthritis, Rheumatoid Asthma Atrial Fibrillation Autoimmune Diseases Autoimmune Diseases of the Nervous System Bacterial Infections Bacterial Infections and Mycoses Basal Ganglia Diseases Behavior Behavioral Symptoms Bone Diseases Bone Diseases, Metabolic Borrelia Infections Brain Damage, Chronic Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Bronchial Diseases Cancer Brain Cancer Colon Cancer Prostate Cancer Skin Cancer, Breast Cancer, Lung Cancer, Other Cancer, Ovarian Cancer, Thyroid Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Palsy Cerebrovascular Disorders Chest Pain Chronic Disease Chronic Fatigue Syndrome Chronic Kidney Diseases Chronic Obstructive Pulmonary Disease (COPD) Cluster Headache Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Colonic Neoplasms Colorectal Neoplasms Connective Tissue Diseases Crohn Disease Cysts Deafness Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Dermatitis Diabetes Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Disease Attributes Ear Diseases Eczema Encephalomyelitis Endocrine Gland Neoplasms Endocrine System Diseases Epilepsy Eye Diseases Fatigue Syndrome, Chronic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibroids Fibromyalgia Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glucose Metabolism Disorders Gonadal Disorders Gram-Negative Bacterial Infections Head and Neck Neoplasms Headache Disorders Headache Disorders, Primary Hearing Disorders Hearing Loss Heart Diseases Heart Failure Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Hypertension Hyperthyroidism Hypothyroidism Immune System Diseases Immunoproliferative Disorders Infections Infertility Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Joint Diseases Kidney Diseases Leiomyoma Lung Diseases Lung Diseases, Obstructive Lung Neoplasms Lyme Disease Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Macular Degeneration Male Urogenital Diseases Mental Disorders Metabolic Diseases Migraine Migraine Disorders Motor Neuron Disease Movement Disorders Multiple Allergies Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Myocardial Ischemia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Nervous System Diseases Nervous System Neoplasms Neurobehavioral Manifestations Neurodegenerative Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Osteoarthritis Osteoporosis Otorhinolaryngologic Diseases Ovarian Cysts Ovarian Diseases Ovarian Neoplasms Pain Pain, Postoperative Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Phantom Limb Pain Post Traumatic Stress Disorder (PTSD) Postoperative Complications Prostatic Diseases Prostatic Neoplasms Proteostasis Deficiencies Psoriasis Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Neoplasms Retinal Degeneration Retinal Diseases Rheumatic Diseases Rheumatoid Arthritis Sensation Disorders Signs and Symptoms Sjogrens Disease Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin Neoplasms Skin and Connective Tissue Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Spinal Diseases Spinal Stenosis Spirochaetales Infections Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stroke Synucleinopathies TDP-43 Proteinopathies Tension Headache Tension-Type Headache Thoracic Neoplasms Throat Cancer Thyroid Diseases Thyroid Neoplasms Tick-Borne Diseases Tinnitus Trauma and Stressor Related Disorders Trauma, Nervous System Trigeminal Autonomic Cephalalgias Ulcerative Colitis Urogenital Diseases Urogenital Neoplasms Urologic Diseases Vascular Diseases Vector Borne Diseases Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VitaMed Research, LLC

Palm Desert, California, 92260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tobias Moeller-Bertram

Industry

Collaborators

  • Metamorphosis, LLC
  • University of California, San Diego

Registry information

Official study title

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

Acronym: QUANTUM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.