Clinical trial NCT04366544: Effects of an 8-day Advanced Meditation, Samyama on Physical, Psychological and Spiritual Wellbeing ,and Associated Neural Mechanisms
Official title: Effects of an 8-day Advanced Meditation Samyama, on Physical, Psychological and Spiritual Well-being ,and Associated Neural Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Happiness
Depression
Consciousness, Level Altered
Ecstasy
Dietary Habits
Stress
Inflammatory Bowel Diseases
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Potential participants 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. 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 blood and/or stool samples.

\*Up to 200 volunteers at Isha can participate in blood draws. Upto 25 subjects will also be enrolled in the (2)EEG and (2)fMRI Study before and after Samyama.
Primary purpose: OTHER

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 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.

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, 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).

Eligibility criteria: 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.

Primary outcomes:
measure: levels of Anandamide
timeFrame: 4 months
measure: Levels of Brain Derived Neurotrophic Factor (BDNF)
timeFrame: 4 months
measure: Transcriptome analysis
timeFrame: 4 months
measure: Epigenetic analysis (DNA methylation)
timeFrame: 4 months
Secondary outcomes:
measure: Microbiome analysis:
timeFrame: 4 months
measure: Gut Inflammation analysis:
timeFrame: 4 months
measure: Plasma lipidomic analyses:
timeFrame: 4 Months
Other outcomes:
measure: fMRI
timeFrame: 4 months
measure: EEG
timeFrame: 4 months
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Senthilkumar Sadhasivam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vishnubhotla RV, Wood PL, Verma A, Cebak JE, Hariri S, Mudigonda M, Alankar S, Maturi R, Orui H, Subramaniam B, Palwale D, Renschler J, Sadhasivam S. Advanced Meditation and Vegan Diet Increased Acylglycines and Reduced Lipids Associated with Improved Health: A Prospective Longitudinal Study. J Integr Complement Med. 2022 Aug;28(8):674-682. doi: 10.1089/jicm.2022.0480. Epub 2022 May 9.
citation: Vishnubhotla RV, Radhakrishnan R, Kveraga K, Deardorff R, Ram C, Pawale D, Wu YC, Renschler J, Subramaniam B, Sadhasivam S. Advanced Meditation Alters Resting-State Brain Network Connectivity Correlating With Improved Mindfulness. Front Psychol. 2021 Nov 18;12:745344. doi: 10.3389/fpsyg.2021.745344. eCollection 2021.