Quest to Analyze One Thousand Humans Meditating
NCT Number: NCT06583395
Acronym: QUANTUM
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
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
Interventions: BEHAVIORAL: Advanced multi-component meditation practice
Sponsor: Tobias Moeller-Bertram
Collaborators: Metamorphosis, LLC|University of California, San Diego
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-12-05
Completion Date: 2025-03-25
Locations: VitaMed Research, LLC, Palm Desert, California, 92260, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Assess the Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health for Multiple Disease States, 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, 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, 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