Amyotrophic Lateral Sclerosis (ALS)QUANTUMNCT06583395
Quest to Analyze One Thousand Humans Meditating
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Angina, Stable, run by Tobias Moeller-Bertram at 1 site in United States.
Trial summary
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Angina, Stable, Anxiety
- What is being tested?
- Advanced multi-component meditation practice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2021to 25 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All study participants are registered for the advanced meditation retreat.
Who may be able to join
- Must be at 21 years of age or older
- Must speak English
- Must be a registered attendee of the advanced 7-Day meditation retreat
- Must be willing to wear a Garmin device for the entire retreat
- Must complete the research consent to participate in the study
- Must be willing to complete self-report surveys for physical and emotional well-being
Who cannot join
- Younger than 21 years of age
- Non-English speaking
- Not a registered attendee of the advanced 7-Day meditation retreat
- Not willing to wear a Garmin device for the entire meditation retreat
- Did not complete the research consent
- Not willing or able to complete all self-report surveys
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VitaMed Research, LLC
Palm Desert, California, 92260
About this study
Official title: Effects Of Meditation On The Gut Microbiome And Human Health and Disease
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.
Read the detailed description
Meditation and other mind-body interventions (MBIs) have been shown to have a range of health benefits, including an improved stress response, a reduction in inflammatory processes, and an enhanced innate immune response. While several studies on MBIs have been carried out to assess metabolomic, transcriptomic, epigenomic, or physiological outcomes, comprehensive studies including all of these components have not been reported. In addition, most studies have been small, comprised of less than 100 research subjects.
One particular area of meditation research that remains largely unexplored is the gut. A bi-directional communication occurs between the gut and the brain, thus, the gut microbiota can influence behavior, resulting in psychosocial stress and negatively impacting the microbiome. One would predict, then, that meditation-based reductions in stress would have positive effects on gut microbial makeup. Importantly, diseased states are characterized by specific gut microbiome profiles, thus, one can use the microbiome to assay for meditation-induced changes in these states.
In this study, a comprehensive multi-omic analysis will be carried out to determine the effect of an immersive 7-day meditation experience in a retreat setting in a large 2000+ person cohort. Metagenomic analysis will be performed on the gut microbiome, including healthy and clinical populations, to assess disease-specific improvements (Phase 1). In addition, Garmin wearable technology will be used to collect biometric health data, including heart rate, sleep, stress, and activity, for up to 10 months after the meditation retreat (Phase 1). In Phase 2 of this study, the biological analyses will be expanded to include blood and urine. Taken together, these data will be coupled with self-report surveys of physical and emotional health and integrated into a machine-learning platform to assess microbiome shifts tied with epigenetics, proteomics, metabolomics, transformational language, and improvements in health.
The advanced week-long meditation retreat will include approximately 25 hours of instruction and 35 hours of meditation. The meditations will include elements of focused attention, non-dual awareness, and loving kindness compassion techniques. While these meditations are unique to this meditation teacher, they are centered around Kundalini and Vipassana techniques. The meditations will be carried out seated, standing, lying down, and walking. The retreat setting allows for controlling many variables, including sleep schedule, meditation schedule, and diet.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Angina, Stable, Anxiety, Asthma, Atrial Fibrillation, Cancer Brain
- Being tested
- Advanced multi-component meditation practice
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Angina, Stable, Anxiety Disorders, Asthma, Atrial Fibrillation, Brain Neoplasms, Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced multi-component meditation practiceBehavioural
The study intervention is a multi-component advanced guided meditation practice that incorporates elements of focused attention, non-dual, and loving kindness and compassion meditation techniques as well as breathwork components. The practice includes sitting, lying down, standing, and walking components and is carried out at 7-day advanced meditation retreats lead by Joe Dispenza, D.C. These retreats include lecture-based instruction and up to 35 hours of meditation practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Meditation in an Advanced Retreat Setting on Heart Rate Variability in a Global Population
In Phases 1, 2, and 3 of this study, heart rate data will be collected using a Garmin wrist device at the beginning of the meditation retreat and continuously for up to ten months after the retreat. Beat-to-beat interval data will be used to calculate heart rate variability. Time domain measures will include the mean of R-R intervals (mRR), standard deviation of all R-R intervals (SDRR), root mean square of successive R-R differences (RMSSD), and the percentage of R-R intervals that vary by at least 50 ms (pRR50). Frequency domain measures will include very low frequency (VLF), low frequency (LF), and high frequency (HF) measures.
Measured: 4 years
Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites in a Global Population.
In Phases 1, 2, and 3 of this study, metagenomic analysis will be carried out on stool samples collected before and after the retreat. This analysis will assess changes in gut microbes and metabolites as a function of multiple variables, including age and sex.
Measured: 4 years
Effect of Meditation in an Advanced Retreat Setting on the Multi-omic Expression of Genes, Proteins, and Metabolites in the Blood in a Global Population
In Phases 2 and 3 of this study, an integrative analysis of multi-omic assessments will be carried out in whole blood and plasma samples collected before and after the retreat. Whole blood will be analyzed for gene expression while proteomic and metabolomic analysis will be carried out in blood plasma.
Measured: 4 years
Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health outcomes in a global population.
In Phases 1, 2, and 3 of this study, physical and emotional states will be assessed using the Short Form (SF)-36 self-report survey instrument. This scale includes measures for the following domains: bodily pain, general health, mental health, physical functioning, role emotional, role physical, social functioning, and vitality. Data will be reported as the average percent change from baseline to follow-up for each domain. When necessary, data will be rescaled such that positive values will indicate improvement from pre- to post-retreat.
Measured: 4 years
Secondary outcomes (3)
Assess the Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health for Multiple Disease States
In Phases 1, 2, and 3 of this study, demographic data will be collected to assess the health status of each study subject including all physical and emotional conditions. Physical and emotional health will be assessed using the Short Form (SF)-36 self-report survey instrument. This scale includes measures for the following domains: bodily pain, general health, mental health, physical functioning, role emotional, role physical, social functioning, and vitality. Data will be reported as the average percent change from baseline to follow-up for each domain. When necessary, data will be rescaled such that positive values will indicate improvement from pre- to post-retreat.
Measured: 4 years
Assess the Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites for Multiple Disease States
In Phases 1, 2, and 3 of this study, metagenomic data generated in Primary Outcome #2 will be stratified by health condition. These data will highlight specific changes in gut microbes and metabolites resulting from the meditation retreat.
Measured: 4 years
Assess the Effect of Meditation in an Advanced Retreat Setting on the Differential Expression of Genes, Proteins, and Metabolites in Blood for Multiple Disease States
In Phases 2 and 3 of this study, transcriptomic, proteomic, and metabolomic data generated in Primary Outcome #3 will be stratified by health condition. These data will highlight specific changes in gene expression, protein expression, and metabolites resulting from the meditation retreat.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start5 Dec 2021
- Primary completion25 Mar 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tobias Moeller-Bertram
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Metamorphosis, LLC, University of California, San Diego
- Responsible party
- Sponsor-investigator, Tobias Moeller-Bertram, VitaMed Research LLC
- Investigators
- Tobias Moeller-Bertram, MD, Principal investigator, VitaMed Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583395
- Sponsor's protocol ID
- 20211477A
- Acronym
- QUANTUM
- Status last verified
- Oct 2024
- First submitted
- 29 Nov 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiesa A, Serretti A. Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. J Altern Complement Med. 2009 May;15(5):593-600. doi: 10.1089/acm.2008.0495.
PubMed 19432513Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.
PubMed 28670311Muehsam D, Lutgendorf S, Mills PJ, Rickhi B, Chevalier G, Bat N, Chopra D, Gurfein B. The embodied mind: A review on functional genomic and neurological correlates of mind-body therapies. Neurosci Biobehav Rev. 2017 Feb;73:165-181. doi: 10.1016/j.neubiorev.2016.12.027. Epub 2016 Dec 23.
PubMed 28017838Kox M, van Eijk LT, Zwaag J, van den Wildenberg J, Sweep FC, van der Hoeven JG, Pickkers P. Voluntary activation of the sympathetic nervous system and attenuation of the innate immune response in humans. Proc Natl Acad Sci U S A. 2014 May 20;111(20):7379-84. doi: 10.1073/pnas.1322174111. Epub 2014 May 5.
PubMed 24799686Chandran V, Bermudez ML, Koka M, Chandran B, Pawale D, Vishnubhotla R, Alankar S, Maturi R, Subramaniam B, Sadhasivam S. Large-scale genomic study reveals robust activation of the immune system following advanced Inner Engineering meditation retreat. Proc Natl Acad Sci U S A. 2021 Dec 21;118(51):e2110455118. doi: 10.1073/pnas.2110455118.
PubMed 34907015Bhasin MK, Dusek JA, Chang BH, Joseph MG, Denninger JW, Fricchione GL, Benson H, Libermann TA. Relaxation response induces temporal transcriptome changes in energy metabolism, insulin secretion and inflammatory pathways. PLoS One. 2013 May 1;8(5):e62817. doi: 10.1371/journal.pone.0062817. Print 2013.
PubMed 23650531Antoni MH, Lutgendorf SK, Blomberg B, Carver CS, Lechner S, Diaz A, Stagl J, Arevalo JM, Cole SW. Cognitive-behavioral stress management reverses anxiety-related leukocyte transcriptional dynamics. Biol Psychiatry. 2012 Feb 15;71(4):366-72. doi: 10.1016/j.biopsych.2011.10.007. Epub 2011 Nov 16.
PubMed 22088795Black DS, Cole SW, Irwin MR, Breen E, St Cyr NM, Nazarian N, Khalsa DS, Lavretsky H. Yogic meditation reverses NF-kappaB and IRF-related transcriptome dynamics in leukocytes of family dementia caregivers in a randomized controlled trial. Psychoneuroendocrinology. 2013 Mar;38(3):348-55. doi: 10.1016/j.psyneuen.2012.06.011. Epub 2012 Jul 15.
PubMed 22795617Ohnishi J, Ayuzawa S, Nakamura S, Sakamoto S, Hori M, Sasaoka T, Takimoto-Ohnishi E, Tanatsugu M, Murakami K. Distinct transcriptional and metabolic profiles associated with empathy in Buddhist priests: a pilot study. Hum Genomics. 2017 Sep 2;11(1):21. doi: 10.1186/s40246-017-0117-3.
PubMed 28865488Chaix R, Fagny M, Cosin-Tomas M, Alvarez-Lopez M, Lemee L, Regnault B, Davidson RJ, Lutz A, Kaliman P. Differential DNA methylation in experienced meditators after an intensive day of mindfulness-based practice: Implications for immune-related pathways. Brain Behav Immun. 2020 Feb;84:36-44. doi: 10.1016/j.bbi.2019.11.003. Epub 2019 Nov 13.
PubMed 31733290Venditti S, Verdone L, Reale A, Vetriani V, Caserta M, Zampieri M. Molecules of Silence: Effects of Meditation on Gene Expression and Epigenetics. Front Psychol. 2020 Aug 11;11:1767. doi: 10.3389/fpsyg.2020.01767. eCollection 2020.
PubMed 32849047Alvarez-Lopez MJ, Conklin QA, Cosin-Tomas M, Shields GS, King BG, Zanesco AP, Kaliman P, Saron CD. Changes in the expression of inflammatory and epigenetic-modulatory genes after an intensive meditation retreat. Compr Psychoneuroendocrinol. 2022 Jun 23;11:100152. doi: 10.1016/j.cpnec.2022.100152. eCollection 2022 Aug.
PubMed 35818436Househam AM, Peterson CT, Mills PJ, Chopra D. The Effects of Stress and Meditation on the Immune System, Human Microbiota, and Epigenetics. Adv Mind Body Med. 2017 Fall;31(4):10-25.
PubMed 29306937
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Meditation On The Gut Microbiome And Human Health and Disease
- ClinicalTrials.gov ID
- NCT06583395
- Acronym / sponsor ID
- QUANTUM / 20211477A
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Angina, Stable, Anxiety, Asthma, Atrial Fibrillation, Cancer Brain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Tobias Moeller-BertramIndustry (pharma, biotech, devices)
- Collaborators
- Metamorphosis, LLC, University of California, San Diego
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 4 Sep 2024 (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.
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.
Detailed description
Meditation and other mind-body interventions (MBIs) have been shown to have a range of health benefits, including an improved stress response, a reduction in inflammatory processes, and an enhanced innate immune response. While several studies on MBIs have been carried out to assess metabolomic, transcriptomic, epigenomic, or physiological outcomes, comprehensive studies including all of these components have not been reported. In addition, most studies have been small, comprised of less than 100 research subjects.
One particular area of meditation research that remains largely unexplored is the gut. A bi-directional communication occurs between the gut and the brain, thus, the gut microbiota can influence behavior, resulting in psychosocial stress and negatively impacting the microbiome. One would predict, then, that meditation-based reductions in stress would have positive effects on gut microbial makeup. Importantly, diseased states are characterized by specific gut microbiome profiles, thus, one can use the microbiome to assay for meditation-induced changes in these states.
In this study, a comprehensive multi-omic analysis will be carried out to determine the effect of an immersive 7-day meditation experience in a retreat setting in a large 2000+ person cohort. Metagenomic analysis will be performed on the gut microbiome, including healthy and clinical populations, to assess disease-specific improvements (Phase 1). In addition, Garmin wearable technology will be used to collect biometric health data, including heart rate, sleep, stress, and activity, for up to 10 months after the meditation retreat (Phase 1). In Phase 2 of this study, the biological analyses will be expanded to include blood and urine. Taken together, these data will be coupled with self-report surveys of physical and emotional health and integrated into a machine-learning platform to assess microbiome shifts tied with epigenetics, proteomics, metabolomics, transformational language, and improvements in health.
The advanced week-long meditation retreat will include approximately 25 hours of instruction and 35 hours of meditation. The meditations will include elements of focused attention, non-dual awareness, and loving kindness compassion techniques. While these meditations are unique to this meditation teacher, they are centered around Kundalini and Vipassana techniques. The meditations will be carried out seated, standing, lying down, and walking. The retreat setting allows for controlling many variables, including sleep schedule, meditation schedule, and diet.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All study participants are registered for the advanced meditation retreat.
Key inclusion criteria (6 listed)
- Must be at 21 years of age or older
- Must speak English
- Must be a registered attendee of the advanced 7-Day meditation retreat
- Must be willing to wear a Garmin device for the entire retreat
- Must complete the research consent to participate in the study
Key exclusion criteria (6 listed)
- Younger than 21 years of age
- Non-English speaking
- Not a registered attendee of the advanced 7-Day meditation retreat
- Not willing to wear a Garmin device for the entire meditation retreat
- Did not complete the research consent
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 |
|---|---|---|
| Advanced multi-component meditation practiceThe study intervention is a multi-component advanced guided meditation practice that incorporates elements of focused attention, non-dual, and loving kindness and compassion meditation techniques as well as breathwork components. The practice includes sitting, lying down, standing, and walking components and is carried out at 7-day advanced meditation retreats lead by Joe Dispenza, D.C. These retreats include lecture-based instruction and up to 35 hours of meditation practice. | Behavioural | – |
Primary outcome
Effect of Meditation in an Advanced Retreat Setting on Heart Rate Variability in a Global Population
Time frame: 4 years
In Phases 1, 2, and 3 of this study, heart rate data will be collected using a Garmin wrist device at the beginning of the meditation retreat and continuously for up to ten months after the retreat. Beat-to-beat interval data will be used to calculate heart rate variability. Time domain measures will include the mean of R-R intervals (mRR), standard deviation of all R-R intervals (SDRR), root mean square of successive R-R differences (RMSSD), and the percentage of R-R intervals that vary by at least 50 ms (pRR50). Frequency domain measures will include very low frequency (VLF), low frequency (LF), and high frequency (HF) measures.
Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites in a Global Population.
Time frame: 4 years
In Phases 1, 2, and 3 of this study, metagenomic analysis will be carried out on stool samples collected before and after the retreat. This analysis will assess changes in gut microbes and metabolites as a function of multiple variables, including age and sex.
Effect of Meditation in an Advanced Retreat Setting on the Multi-omic Expression of Genes, Proteins, and Metabolites in the Blood in a Global Population
Time frame: 4 years
In Phases 2 and 3 of this study, an integrative analysis of multi-omic assessments will be carried out in whole blood and plasma samples collected before and after the retreat. Whole blood will be analyzed for gene expression while proteomic and metabolomic analysis will be carried out in blood plasma.
Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health outcomes in a global population.
Time frame: 4 years
In Phases 1, 2, and 3 of this study, physical and emotional states will be assessed using the Short Form (SF)-36 self-report survey instrument. This scale includes measures for the following domains: bodily pain, general health, mental health, physical functioning, role emotional, role physical, social functioning, and vitality. Data will be reported as the average percent change from baseline to follow-up for each domain. When necessary, data will be rescaled such that positive values will indicate improvement from pre- to post-retreat.
3 secondary outcomes
Assess the Effect of Meditation in an Advanced Retreat Setting on Physical and Emotional Health for Multiple Disease States
Time frame: 4 years
Assess the Effect of Meditation in an Advanced Retreat Setting on the Gut Microbiome and Metabolites for Multiple Disease States
Time frame: 4 years
Assess the Effect of Meditation in an Advanced Retreat Setting on the Differential Expression of Genes, Proteins, and Metabolites in Blood for Multiple Disease States
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 19432513Chiesa A, Serretti A. Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. J Altern Complement Med. 2009 May;15(5):593-600. doi: 10.1089/acm.2008.0495.
- Background: PubMed 28670311Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.
- Background: PubMed 28017838Muehsam D, Lutgendorf S, Mills PJ, Rickhi B, Chevalier G, Bat N, Chopra D, Gurfein B. The embodied mind: A review on functional genomic and neurological correlates of mind-body therapies. Neurosci Biobehav Rev. 2017 Feb;73:165-181. doi: 10.1016/j.neubiorev.2016.12.027. Epub 2016 Dec 23.
- Background: PubMed 24799686Kox M, van Eijk LT, Zwaag J, van den Wildenberg J, Sweep FC, van der Hoeven JG, Pickkers P. Voluntary activation of the sympathetic nervous system and attenuation of the innate immune response in humans. Proc Natl Acad Sci U S A. 2014 May 20;111(20):7379-84. doi: 10.1073/pnas.1322174111. Epub 2014 May 5.
- Background: PubMed 34907015Chandran V, Bermudez ML, Koka M, Chandran B, Pawale D, Vishnubhotla R, Alankar S, Maturi R, Subramaniam B, Sadhasivam S. Large-scale genomic study reveals robust activation of the immune system following advanced Inner Engineering meditation retreat. Proc Natl Acad Sci U S A. 2021 Dec 21;118(51):e2110455118. doi: 10.1073/pnas.2110455118.
- Background: PubMed 23650531Bhasin MK, Dusek JA, Chang BH, Joseph MG, Denninger JW, Fricchione GL, Benson H, Libermann TA. Relaxation response induces temporal transcriptome changes in energy metabolism, insulin secretion and inflammatory pathways. PLoS One. 2013 May 1;8(5):e62817. doi: 10.1371/journal.pone.0062817. Print 2013.
- Background: PubMed 22088795Antoni MH, Lutgendorf SK, Blomberg B, Carver CS, Lechner S, Diaz A, Stagl J, Arevalo JM, Cole SW. Cognitive-behavioral stress management reverses anxiety-related leukocyte transcriptional dynamics. Biol Psychiatry. 2012 Feb 15;71(4):366-72. doi: 10.1016/j.biopsych.2011.10.007. Epub 2011 Nov 16.
- Background: PubMed 22795617Black DS, Cole SW, Irwin MR, Breen E, St Cyr NM, Nazarian N, Khalsa DS, Lavretsky H. Yogic meditation reverses NF-kappaB and IRF-related transcriptome dynamics in leukocytes of family dementia caregivers in a randomized controlled trial. Psychoneuroendocrinology. 2013 Mar;38(3):348-55. doi: 10.1016/j.psyneuen.2012.06.011. Epub 2012 Jul 15.
- Background: PubMed 28865488Ohnishi J, Ayuzawa S, Nakamura S, Sakamoto S, Hori M, Sasaoka T, Takimoto-Ohnishi E, Tanatsugu M, Murakami K. Distinct transcriptional and metabolic profiles associated with empathy in Buddhist priests: a pilot study. Hum Genomics. 2017 Sep 2;11(1):21. doi: 10.1186/s40246-017-0117-3.
- Background: PubMed 31733290Chaix R, Fagny M, Cosin-Tomas M, Alvarez-Lopez M, Lemee L, Regnault B, Davidson RJ, Lutz A, Kaliman P. Differential DNA methylation in experienced meditators after an intensive day of mindfulness-based practice: Implications for immune-related pathways. Brain Behav Immun. 2020 Feb;84:36-44. doi: 10.1016/j.bbi.2019.11.003. Epub 2019 Nov 13.
- Background: PubMed 32849047Venditti S, Verdone L, Reale A, Vetriani V, Caserta M, Zampieri M. Molecules of Silence: Effects of Meditation on Gene Expression and Epigenetics. Front Psychol. 2020 Aug 11;11:1767. doi: 10.3389/fpsyg.2020.01767. eCollection 2020.
- Background: PubMed 35818436Alvarez-Lopez MJ, Conklin QA, Cosin-Tomas M, Shields GS, King BG, Zanesco AP, Kaliman P, Saron CD. Changes in the expression of inflammatory and epigenetic-modulatory genes after an intensive meditation retreat. Compr Psychoneuroendocrinol. 2022 Jun 23;11:100152. doi: 10.1016/j.cpnec.2022.100152. eCollection 2022 Aug.
- Individual participant dataSharing planned: No
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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.
Tobias Moeller-Bertram, MD principal investigator
VitaMed Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS) and Angina, Stable, run by Tobias Moeller-Bertram 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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 1 Nov 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?
This study is still under way. Results are not available in the source record yet.
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?
Effect of Meditation in an Advanced Retreat Setting on Heart Rate Variability in a Global Population (time frame: 4 years). 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 NCT06583395, which also lists 13 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 1 Nov 2024.