Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04366544
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2020-04-17
Brief Title:
Effects of an 8-day Advanced Meditation Samyama on Physical Psychological and Spiritual Wellbeing and Associated Neural Mechanisms
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Effects of an 8-day Advanced Meditation Samyama on Physical Psychological and Spiritual Well-being and Associated Neural Mechanisms
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the effects of Samyama program on blood levels of selected neurotransmitters before and after the program and associate with corresponding effects on mindpsyche before and after the program in adult participants
Hypothesis
1 The state of higher consciousness and ecstasy resulting from Samyama result from increased levels of Anandamide an endocannabinoid and Brain Derived Neurotrophic Factor BDNF
2 The 60-day preparatory phase that includes dietary regulation and yogic practices will reduce the gut inflammation and thereby will improve the gut microbiome
Hypothesis
1 The state of higher consciousness and ecstasy resulting from Samyama result from increased levels of Anandamide an endocannabinoid and Brain Derived Neurotrophic Factor BDNF
2 The 60-day preparatory phase that includes dietary regulation and yogic practices will reduce the gut inflammation and thereby will improve the gut microbiome
Detailed Description:
Potential participants those signed up to attend the Samyama program at Isha will be sent email invitations approximately 2 months prior to the program Participants will have the options to take part in online surveys blood samples andor stool samples Up to 1000 participants attendees and spousessignificant others may take the online surveys twice before the samyama program 2 weeks after and 3 months after Up to 200 may volunteer to have 4 blood draws Blood draws will occur 1 At home or at an Isha group meditation 1-2 months prior to Samyama 2 At Isha before the start of the program 3 At Isha after the program 4 At home after returning from the Samyama program 150 volunteers may also send in 3 stool samples - 1 prior to starting the Samyama pre-prep diet 2 within one week of the Samyama program 3 After returning home from the program
Up to 50 spousessignificant others living with Samyama attendees will also be offered the opportunity to complete a shortened version of the online surveys provide 2 blood andor 3 stool samples Blood would be collected at home prior to their spousessignificant others Samyama attendance and in their home after the program Requested stool samples would be asked to be collected approximately 1 month prior to the program 1 week prior to the program and one week after the program
Blood samples will be sent to Indiana University and may be sent to other specialty labs for additional analysis Genetic and future biomarker samples will be stored at the PIs Indiana University lab facilities
If survey participants do not complete surveys during suggested time periods they may also be sent reminders via emails to complete surveys
Only up to 150 volunteers will have at home blood draws or blood draws at an Isha group meditation Only those who participated in the pre-Samyama at home blood draws will be asked to participate in the post-Samyama blood draws
Up to 200 volunteers at Isha can participate in blood draws regardless of whether they participated in at home blood draw
Those who complete the survey will also be asked if they have a significant other or spouse who lives with them who would be willing to complete surveys and participate in blood draws andor provide stool samples Participants with willing spouses will be asked to enter an email address for that spousesignificant other Spousesignificant other will be emailed the invitation with study information
Upto 25 subjects will also be enrolled in the 2EEG and 2fMRI Study March 19 and March 29 2018 before Samyama and between April 9th and May 9th 2018 after Samyama
Up to 50 spousessignificant others living with Samyama attendees will also be offered the opportunity to complete a shortened version of the online surveys provide 2 blood andor 3 stool samples Blood would be collected at home prior to their spousessignificant others Samyama attendance and in their home after the program Requested stool samples would be asked to be collected approximately 1 month prior to the program 1 week prior to the program and one week after the program
Blood samples will be sent to Indiana University and may be sent to other specialty labs for additional analysis Genetic and future biomarker samples will be stored at the PIs Indiana University lab facilities
If survey participants do not complete surveys during suggested time periods they may also be sent reminders via emails to complete surveys
Only up to 150 volunteers will have at home blood draws or blood draws at an Isha group meditation Only those who participated in the pre-Samyama at home blood draws will be asked to participate in the post-Samyama blood draws
Up to 200 volunteers at Isha can participate in blood draws regardless of whether they participated in at home blood draw
Those who complete the survey will also be asked if they have a significant other or spouse who lives with them who would be willing to complete surveys and participate in blood draws andor provide stool samples Participants with willing spouses will be asked to enter an email address for that spousesignificant other Spousesignificant other will be emailed the invitation with study information
Upto 25 subjects will also be enrolled in the 2EEG and 2fMRI Study March 19 and March 29 2018 before Samyama and between April 9th and May 9th 2018 after Samyama
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None