Clinical trial NCT06583395: Quest to Analyze One Thousand Humans Meditating
Official title: Effects Of Meditation On The Gut Microbiome And Human Health and Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: VitaMed Research LLC
Sponsor class: INDUSTRY
Collaborators: name: Metamorphosis, LLC
name: University of California, San Diego
First posted: 2024-09-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants are registered for the advanced meditation retreat.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Meditation in an Advanced Retreat Setting on Heart Rate Variability in a Global Population
timeFrame: 4 years
measure: Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites in a Global Population.
timeFrame: 4 years
measure: 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
timeFrame: 4 years
measure: Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health outcomes in a global population.
timeFrame: 4 years
Secondary outcomes:
measure: Assess the Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health for Multiple Disease States
timeFrame: 4 years
measure: Assess the Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites for Multiple Disease States
timeFrame: 4 years
measure: 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
timeFrame: 4 years
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: VitaMed Research, LLC
state: California
Study officials:
affiliation: VitaMed Research LLC
name: Tobias Moeller-Bertram, MD
role: PRINCIPAL_INVESTIGATOR
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