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Trials / Enrolling By Invitation

Enrolling By InvitationNCT06583395

Quest to Analyze One Thousand Humans Meditating

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

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
3,000 (estimated)
Sponsor
Tobias Moeller-Bertram · Industry
Sex
All
Age
21 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAdvanced multi-component meditation practiceThe 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.

Timeline

Start date
2021-12-05
Primary completion
2025-03-25
Completion
2025-03-25
First posted
2024-09-04
Last updated
2024-11-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06583395. Inclusion in this directory is not an endorsement.