Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583395
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2023-11-29
Brief Title:
Quest to Analyze One Thousand Humans Meditating
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects Of Meditation On The Gut Microbiome And Human Health and Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUANTUM
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None