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

NCT04366544 | Completed

• 1 other identifier: 1801728792
• Study Type: interventional
• Target: 759
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• levels of Anandamide

  Anandamide (AEA) activates endocannabinoid-1 (eCB1) receptors in the central nervous system and eCB2 receptors throughout the body and studies have suggested its role in regulating mood and behavior, sleeping and eating patterns, memory, pain, immune system, fertility and cancer inhibition \[3\]. Endogenous anandamide is mainly active at eCB1 receptor, which is responsible for the experience of blissfulness, ecstasy and the elevated mood and wellbeing similar to psychoactive effects reported in cannabis use. Anandamide is thought to be related to the experience of "runner's high" due to intense physical activity \[4\]. So far, no study has explored the effect of yoga and meditation on endogenous levels of anandamide in humans. However, Anandamide is very quickly catabolized in the human system by Fatty Acid Amide Hydrolase (FAAH) \[5\]. So, to control for this we propose to use FAAH inhibitor in the sampling tube to preserve and accurately measure anandamide.

  4 months

• Levels of Brain Derived Neurotrophic Factor (BDNF)

  Brain-derived neurotrophic factor (BDNF) is another neurotransmitter found in the brain and the rest of the body. It helps in survival of existing neurons and growth of new neurons. It is involved in regulation of other neurotransmitters, long-term memory, stable memory function and cognitive function \[6, 7\]. Studies have suggested negative correlations between BDNF levels and disease such as depression, schizophrenia, obsessive-compulsive disorder, Alzheimer's disease, anorexia and dementia. Studies have shown beneficial increase in BDNF levels in human subjects because of yoga and meditation practices \[8\].

  4 months

• Transcriptome analysis

  Transcriptome analysis (RNA sequencing - gene expression analyses): Peripheral blood from participants will be collected before and after Samyama in PAXgene Blood RNA Tubes (Qiagen). Upon RNA extraction, RNA quantity will be assessed with Nanodrop (Nanodrop Technologies) and quality with the Agilent Bioanalyzer (Agilent Technologies). RNA samples will be cleaned using DNAse I kit according to the Rapid out removal DNA kit instruction (Thermoscientific) and will be converted into cDNA by using Lexogen QuantSeq 3' Fwd Library Prep Kit (Lexogen) according to manufacturer's instruction to generate compatible library for Illumina sequencing. cDNA libraries will be assessed using TapeStation (Agilent Technologies, USA) before 65-100 bp single end sequencing using Illumina HiSeq 4000 system based on standard protocols to obtain raw sequencing data. Raw sequencing reads will be processed using our standard pipelines to obtain high quality sequencing reads for data analyses.

  4 months

• Epigenetic analysis (DNA methylation)

  Epigenetic analysis (DNA methylation): DNA from peripheral blood of participants will be examined for integrity by agarose gel electrophoresis and quantified using fluorimeter using a double stranded DNA (BR) assay (Thermo Fisher Scientific). About 500 ng of the sampled DNA will be analyzed on a Infinium® MethylationEPIC BeadChip (Illumina, San Diego, CA). The hybridized and stained arrays will be ultimately scanned using HiScanSQ system (Illumina). Infinium MethylationEPIC (EPIC) BeadChip from Illumina will evaluate over 850,000 methylation sites quantitatively across the genome at single-nucleotide resolution. Data analyses will be performed utilizing previously published standard pipelines.

  4 months

Secondary Outcomes (3)

• Microbiome analysis:

  4 months

• Gut Inflammation analysis:

  4 months

• Plasma lipidomic analyses:

  4 Months

Other Outcomes (2)

• fMRI

  4 months

• EEG

  4 months

Study Arms (4)

Time Point 1: Baseline/Pre-preparatory Samyama

OTHER

* 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.

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

Time point 2: Post-Preparatory/Pre-Samyama

OTHER

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

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

Timepoint 3: Immediate Post-Samyama

OTHER

* 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

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

Timepoint 4: 3 months Post Samyama

OTHER

* 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

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

Interventions

Part A1: Survey OTHER

Online

Time Point 1: Baseline/Pre-preparatory Samyama; Time point 2: Post-Preparatory/Pre-Samyama; Timepoint 3: Immediate Post-Samyama; Timepoint 4: 3 months Post Samyama

Part A2: Sample collection OTHER

Blood and Stool

Time Point 1: Baseline/Pre-preparatory Samyama; Time point 2: Post-Preparatory/Pre-Samyama; Timepoint 3: Immediate Post-Samyama; Timepoint 4: 3 months Post Samyama

Part B: OTHER

EEG and fMRI

Time point 2: Post-Preparatory/Pre-Samyama; Timepoint 3: Immediate Post-Samyama

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

• Raman M, Vishnubhotla R, Ramay HR, Goncalves MCB, Shin AS, Pawale D, Subramaniam B, Sadhasivam S. Isha yoga practices, vegan diet, and participation in Samyama meditation retreat: impact on the gut microbiome & metabolome - a non-randomized trial. BMC Complement Med Ther. 2023 Apr 5;23(1):107. doi: 10.1186/s12906-023-03935-8.

  PMID: 37020274 DERIVED

• 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.

  PMID: 35532984 DERIVED

• 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.

  PMID: 34867626 DERIVED

MeSH Terms

Conditions

Depression; Consciousness Disorders; Feeding Behavior; Inflammatory Bowel Diseases

Interventions

Medicare Part B

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavior, Animal; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Medicare; Medical Assistance; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Insurance, Health; Insurance; Legislation as Topic; Social Control, Formal

Study Officials

• Senthilkumar Sadhasivam, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 29, 2020
• Study Start: January 19, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Until the data is completely analyzed
• Access Criteria: Deidentified

Locations

US (1)