HealthyNCT06306469
Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment
A study testing Meditation practice in people with Healthy, run by Pranic Healing Research Institute at 1 site in United States.
Trial summary
The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment. This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meditation practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2022to 11 Jan 2024
- 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
- must provide written informed consent prior to initiation of any study procedures
- was able to understand and agreed to comply with planned study procedures (agreed to the collection of specimens (saliva and fecal) before, during and after the study
- male or non-pregnant female greater than 18 years of age at time of enrolment
- must have a distinct Arhatic level (0-5 level) and performed meditation and MTH practices from once a week to more than 3 times a week prior to this retreat
Who cannot join
- concomitant disease that requires any medical treatment
- pregnancy
- any antibiotic treatment in the past two weeks
- pediatric population
- clinical apparent infectious disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Pranic Healing Research Institute
Lyndhurst, New Jersey, 07071
About this study
Official title: Changes in Microbiota and Biochemical Markers in Healthy Subjects Before and After Meditation Practices in a Controlled Environment
The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.
This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being.
Read the detailed description
The present study was designed as a single-arm pilot scale to understand the temporal changes in both gut and oral microbiome of the practitioners at a meditation-cum-spiritual retreat in a controlled environment. There was open communication between all the participants before, during and after the retreat. As all the practitioners followed group practices in one location under the supervision of the senior instructors, separate assessment of the adherence of the practitioners to the protocol was not performed. Oral and fecal samples of practitioners were collected at the start (Day0: T1), middle (Day3-5: T2) and end (Day7-9:T3) of the retreat in a sterile containers. Amplicon sequencing was performed from extracted DNA to study changes in microbiome profile during retreat.
- Conditions
- Healthy
- Being tested
- Meditation practice
- Keywords
- microbiome, meditation, arhatic yoga, beneficial microbes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation practiceOther
physical and breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| single Arm1 | Experimental | All practitioners had undertaken formal training on Pranic Healing, Meditation on Twin Hearts, and higher meditation practices at least six months prior to the retreat. Daily retreat practices, which lasted typically for 16-18 hours with occasional short breaks. These practices included combinations of specifically designed physical and breathing exercises to improve the energetic states and stillness. Exercises were followed by Pranic Healing and self-awareness practices. Meditations included Meditation on Twin Hearts, Arhatic Yoga meditations of Kundalini meditation, Arhatic Dhyan and Meditation on the Higher Soul . Receives: Other: Meditation practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the changes in gut and oral microbiome profile of the participants during retreat
Stool and oral samples were collected from the participants for three timepoints (T1: 1 day, T2: 3-5 days, and T3: 7-9 days) and changes in gut microbiome and oral microbiome were assessed through 16S rRNA gene amplicon sequencing. T1 was considered as baseline data.
Measured: Timepoint1: 1 day (Baseline), Timepoint2: 3-5 days, and Timepoint3: 7-9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 Jul 2022
- Primary completion9 Jul 2022
- Study completion11 Jan 2024
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 HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pranic Healing Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Mendoza, Principal investigator, Pranic Healing Research Institute,New Jersey, 07071, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306469
- Sponsor's protocol ID
- PHRI-2022-1001
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share the study protocol as well as raw data generated for amplicon sequencing
Publications
Hammerschlag R, Sprengel ML, Baldwin AL. Biofield therapies: Guidelines for reporting clinical trials. Complement Ther Med. 2024 Jun;82:103011. doi: 10.1016/j.ctim.2023.103011. Epub 2024 Feb 1.
PubMed 38307809Raman 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 37020274Househam 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Microbiota and Biochemical Markers in Healthy Subjects Before and After Meditation Practices in a Controlled Environment
- ClinicalTrials.gov ID
- NCT06306469
- Acronym / sponsor ID
- PHRI-2022-1001
- Conditions
- Healthy
- Keywords
- microbiome, meditation, arhatic yoga, beneficial microbes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Pranic Healing Research InstituteUniversity, hospital or other
- Study start
- 2 Jul 2022 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 12 Mar 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.
The goal of the study is to evaluate the Changes in Microbiota Markers in Healthy Subjects Before, During and After Meditation Practices in a Controlled Environment.
This study provides a unique opportunity to test the hypotheses that (1) Arhatic Yoga practices will affect both oral and gut microbiome; (2) the oral and gut microbiome will shift dynamically in a short period; and (3) the overall shift resulting from the changes in the gut microbiome members will be associated with known benefits to health and well-being.
Detailed description
The present study was designed as a single-arm pilot scale to understand the temporal changes in both gut and oral microbiome of the practitioners at a meditation-cum-spiritual retreat in a controlled environment. There was open communication between all the participants before, during and after the retreat. As all the practitioners followed group practices in one location under the supervision of the senior instructors, separate assessment of the adherence of the practitioners to the protocol was not performed. Oral and fecal samples of practitioners were collected at the start (Day0: T1), middle (Day3-5: T2) and end (Day7-9:T3) of the retreat in a sterile containers. Amplicon sequencing was performed from extracted DNA to study changes in microbiome profile during retreat.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single Arm1 | Experimental | Other: Meditation practiceAll practitioners had undertaken formal training on Pranic Healing, Meditation on Twin Hearts, and higher meditation practices at least six months prior to the retreat. Daily retreat practices, which lasted typically for 16-18 hours with occasional short breaks. These practices included combinations of specifically designed physical and breathing exercises to improve the energetic states and stillness. Exercises were followed by Pranic Healing and self-awareness practices. Meditations included Meditation on Twin Hearts, Arhatic Yoga meditations of Kundalini meditation, Arhatic Dhyan and Meditation on the Higher Soul . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must provide written informed consent prior to initiation of any study procedures
- was able to understand and agreed to comply with planned study procedures (agreed to the collection of specimens (saliva and fecal) before, during and after the study
- male or non-pregnant female greater than 18 years of age at time of enrolment
- must have a distinct Arhatic level (0-5 level) and performed meditation and MTH practices from once a week to more than 3 times a week prior to this retreat
Key exclusion criteria (5 listed)
- concomitant disease that requires any medical treatment
- pregnancy
- any antibiotic treatment in the past two weeks
- pediatric population
- clinical apparent infectious disease
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 |
|---|---|---|
| Meditation practicephysical and breathing exercises | Other | single Arm1 |
Primary outcome
Assessing the changes in gut and oral microbiome profile of the participants during retreat
Time frame: Timepoint1: 1 day (Baseline), Timepoint2: 3-5 days, and Timepoint3: 7-9 days
Stool and oral samples were collected from the participants for three timepoints (T1: 1 day, T2: 3-5 days, and T3: 7-9 days) and changes in gut microbiome and oral microbiome were assessed through 16S rRNA gene amplicon sequencing. T1 was considered as baseline data.
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 12 Mar 2024.
- Background: PubMed 38307809Hammerschlag R, Sprengel ML, Baldwin AL. Biofield therapies: Guidelines for reporting clinical trials. Complement Ther Med. 2024 Jun;82:103011. doi: 10.1016/j.ctim.2023.103011. Epub 2024 Feb 1.
- Background: 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.
- Background: PubMed 29306937Househam 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.
- Individual participant dataSharing planned: Yes. Share the study protocol as well as raw data generated for amplicon sequencing
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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.
Glenn Mendoza principal investigator
Pranic Healing Research Institute,New Jersey, 07071, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation practice in people with Healthy, run by Pranic Healing Research Institute 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 4 inclusion and 5 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 12 Mar 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?
Assessing the changes in gut and oral microbiome profile of the participants during retreat (time frame: Timepoint1: 1 day (Baseline), Timepoint2: 3-5 days, and Timepoint3: 7-9 days). 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 NCT06306469, 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 12 Mar 2024.