Mental Health Wellness 1NCT04366544
Effects of an 8-day Advanced Meditation, Samyama on Physical, Psychological and Spiritual Wellbeing ,and Associated Neural Mechanisms
A study testing Part A1: Survey, Part A2: Sample collection and Part B: in people with Mental Health Wellness 1 and Happiness, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Happiness, Depression
- What is being tested?
- Part A1: Survey, Part A2: Sample collection and Part B:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 759 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Advanced meditation program participants age 18 or older (and interested spouses/significant others who live with meditation program participants.)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an 8-day Advanced Meditation Samyama, on Physical, Psychological and Spiritual Well-being ,and Associated Neural Mechanisms
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:
- The state of higher consciousness and ecstasy resulting from Samyama result from increased levels of Anandamide, an endocannabinoid, and Brain Derived Neurotrophic Factor (BDNF).
- The 60-day preparatory phase that includes dietary regulation and yogic practices will reduce the gut inflammation and thereby will improve the gut microbiome.
Read the 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).
- Conditions
- Mental Health Wellness 1, Happiness, Depression, Consciousness, Level Altered, Ecstasy, Dietary Habits
- Being tested
- Part A1: Survey, Part A2: Sample collection, Part B:
- Medical subject headings
- Depression, Consciousness Disorders, Feeding Behavior, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A1: SurveyOther
Online
Part A2: Sample collectionOther
Blood and Stool
Part B:Other
EEG and fMRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: Other: Part A1: Survey; Other: Part A2: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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].
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (3)
Microbiome analysis:
Microbiome analysis: Participants will also be requested for stool samples prior to, or early into the start of preparatory steps (approximately 60 days before the scheduled program start), within 2.5 weeks prior to the program, and another one after the completion of the program. The strict vegan diet and the preparatory steps along with the Samyama meditation program is hypothesized to reduce the gut inflammation and improve the gut microbiome.
Measured: 4 months
Gut Inflammation analysis:
Gut Inflammation analysis: We will explore the relations between perceived stress, blood cortisol, plasma tryptophan catabolites (i.e., kynureine and quinolinic acid), and cytokines potentially related to UC (GM-CSF, Eotaxin, IFN-α, IP-10, IFN-γ, MCP-1, IL-1β, MIG, IL-1RA, MIP-1α, IL-2, MIP-1β, IL-2R, RANTES, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p40/p70), IL-13, IL-15, IL-17, and TNF-α)
Measured: 4 months
Plasma lipidomic analyses:
Plasma lipidomic analyses: A high-resolution (0.2 to 3 ppm mass error) mass spectrometric, non-targeted lipidomics platform will be utilized to compare the plasma lipidome of Samyama participants before and after the program. Blood samples will be collected at the following three time points: (1) before the start of the Samyama program, (2) after the Samyama program, and (3) possibly at 3 months after the program.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start19 Jan 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senthilkumar Sadhasivam, MD, MPH, MBA, Indiana University
- Investigators
- Senthilkumar Sadhasivam, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366544
- Sponsor's protocol ID
- 1801728792
- Status last verified
- Oct 2024
- First submitted
- 17 Apr 2020
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: MRI and EEG data from Indiana University and a collaboring site, part of Harvard University will be combined to increase the statistical power. De-identified MRI and EEG data will be mutually shared with Boston investigators (PI: Dr. Balachundhar Subramaniam).
Publications
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.
PubMed 37020274Vishnubhotla 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.
PubMed 35532984Vishnubhotla 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.
PubMed 34867626
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an 8-day Advanced Meditation Samyama, on Physical, Psychological and Spiritual Well-being ,and Associated Neural Mechanisms
- ClinicalTrials.gov ID
- NCT04366544
- Acronym / sponsor ID
- 1801728792
- Conditions
- Mental Health Wellness 1, Happiness, Depression, Consciousness, Level Altered, Ecstasy, Dietary Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The state of higher consciousness and ecstasy resulting from Samyama result from increased levels of Anandamide, an endocannabinoid, and Brain Derived Neurotrophic Factor (BDNF).
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Time Point 1: Baseline/Pre-preparatory Samyama | Other | Other: Part A1: Survey, Other: Part A2: Sample collection* 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. |
| Time point 2: Post-Preparatory/Pre-Samyama | Other | Other: Part A1: Survey, Other: Part A2: Sample collection, Other: Part B:* Online Surveys * Participant * Spouse * Stool collection from IIIS/home * Blood sample collection: on site at IIIS/home EEG and fMRI |
| Timepoint 3: Immediate Post-Samyama | Other | Other: Part A1: Survey, Other: Part A2: Sample collection, Other: Part B:* 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 |
| Timepoint 4: 3 months Post Samyama | Other | Other: Part A1: Survey, Other: Part A2: Sample collection* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Advanced meditation program participants age 18 or older (and interested spouses/significant others who live with meditation program participants.)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part A1: SurveyOnline | Other | 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 collectionBlood and Stool | Other | 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:EEG and fMRI | Other | Time point 2: Post-Preparatory/Pre-Samyama, Timepoint 3: Immediate Post-Samyama |
Primary outcome
levels of Anandamide
Time frame: 4 months
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.
Levels of Brain Derived Neurotrophic Factor (BDNF)
Time frame: 4 months
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].
Transcriptome analysis
Time frame: 4 months
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.
Epigenetic analysis (DNA methylation)
Time frame: 4 months
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.
3 secondary outcomes
Microbiome analysis:
Time frame: 4 months
Gut Inflammation analysis:
Time frame: 4 months
Plasma lipidomic analyses:
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Derived from this study: PubMed 37020274Raman 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.
- Derived from this study: PubMed 35532984Vishnubhotla 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.
- Derived from this study: PubMed 34867626Vishnubhotla 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.
- Individual participant dataSharing planned: Yes. MRI and EEG data from Indiana University and a collaboring site, part of Harvard University will be combined to increase the statistical power. De-identified MRI and EEG data will be mutually shared with Boston investigators (PI: Dr. Balachundhar Subramaniam).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senthilkumar Sadhasivam, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Part A1: Survey, Part A2: Sample collection and Part B: in people with Mental Health Wellness 1 and Happiness, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of Anandamide (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366544, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.