Quest to Analyze One Thousand Humans Meditating

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06583395
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Tobias Moeller-Bertram
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tobias Moeller-Bertram, MD
Principal Investigator Affiliation VitaMed Research LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

VitaMed Research, LLC, Palm Desert, California

Status

Address

VitaMed Research, LLC

Palm Desert, California, 92260

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