Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment

NCT ID: NCT06306469

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-02

Study Completion Date

2024-01-11

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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single Arm1

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 .

Group Type EXPERIMENTAL

Meditation practice

Intervention Type OTHER

physical and breathing exercises

Interventions

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Meditation practice

physical and breathing exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* concomitant disease that requires any medical treatment
* pregnancy
* any antibiotic treatment in the past two weeks
* pediatric population
* clinical apparent infectious disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pranic Healing Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Mendoza

Role: PRINCIPAL_INVESTIGATOR

Pranic Healing Research Institute,New Jersey, 07071, USA

Locations

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Pranic Healing Research Institute

Lyndhurst, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 38307809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37020274 (View on PubMed)

Househam 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.

Reference Type BACKGROUND
PMID: 29306937 (View on PubMed)

Other Identifiers

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PHRI-2022-1001

Identifier Type: -

Identifier Source: org_study_id

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