Effects of an 8-day Advanced Meditation, Samyama on Physical, Psychological and Spiritual Wellbeing ,and Associated Neural Mechanisms

Indiana University

Status: Completed

Conditions: Happiness; Dietary Habits; Ecstasy; Mental Health Wellness 1; Depression; Inflammatory Bowel Diseases; Consciousness, Level Altered; Stress

Treatments: Other: Part B:; Other: Part A1: Survey; Other: Part A2: Sample collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04366544

1801728792

Details and patient eligibility

About

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 mind/psyche 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.

Full 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, and/or stool samples. Up to 1000 participants (attendees and spouses/significant 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 spouses/significant others living with Samyama attendees will also be offered the opportunity to complete a shortened version of the online surveys, provide (2) blood and/or (3) stool samples. Blood would be collected at home prior to their spouses/significant other's 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 PI's 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 and/or provide stool samples. Participants with willing spouses will be asked to enter an email address for that spouse/significant other. Spouse/significant other will be emailed the invitation with study information.

Upto 25 subjects will also be enrolled in the (2)EEG and (2)fMRI Study March 19 and March 29, 2018 (before Samyama), and between April 9th and May 9th, 2018 (after Samyama).

Enrollment: 759 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Advanced meditation program participants age 18 or older (and interested spouses/significant others who live with meditation program participants.)

Exclusion criteria

1. Inability to read and comprehend the consent form
2. Subjects with medical conditions in which a blood draw would be contra-indicated (e.g. severe anemia).
3. Active marijuana/opioid and related drug use
4. Probiotic or prebiotic supplements within 60 days of enrollment
5. Antibiotic use within 60 days of enrollment
6. Participants living outside of the country.
7. Spouses who indicate in the online survey that they participate in meditation will be excluded from stool and blood samples.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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759 participants in 4 patient groups

Time Point 1: Baseline/Pre-preparatory Samyama

Other group

Description:

* Survey link for participant * Survey link for spouse/ "control" * Stool collection from home * Blood sample at home provided by at home phlebotomy services or at Isha Center group meditation by study personnel.

Treatment:

Other: Part A2: Sample collection

Other: Part A1: Survey

Time point 2: Post-Preparatory/Pre-Samyama

Other group

Description:

* Online Surveys * Participant * Spouse * Stool collection from IIIS/home * Blood sample collection: on site at IIIS/home EEG and fMRI

Treatment:

Other: Part A2: Sample collection

Other: Part A1: Survey

Other: Part B:

Timepoint 3: Immediate Post-Samyama

Other group

Description:

* Online survey to be completed * Survey link for participant * Survey link for spouse * Blood sample collection: on site at IIIS o Participant only - Not spouse/significant other. EEG and fMRI

Treatment:

Other: Part A2: Sample collection

Other: Part A1: Survey

Other: Part B:

Timepoint 4: 3 months Post Samyama

Other group

Description:

* Blood draw at home by at home phlebotomist * Post program online survey follow up to be completed * Survey link for participant * Survey link for spouse: https * Stool collection from home

Treatment:

Other: Part A2: Sample collection

Other: Part A1: Survey