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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Meditation practice

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Lyndhurst, New Jersey, United States, 07071
      • Pranic Healing Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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 .

Other: Meditation practice; physical and breathing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Timepoint1: 1 day (Baseline), Timepoint2: 3-5 days, and Timepoint3: 7-9 days

Collaborators and Investigators

• Sponsor: Pranic Healing Research Institute
• Investigators: Principal Investigator: Glenn Mendoza, Pranic Healing Research Institute,New Jersey, 07071, USA

Publications and helpful links

General Publications

• Hammerschlag R, Sprengel ML, Baldwin AL. Biofield therapies: Guidelines for reporting clinical trials. Complement Ther Med. 2023 Dec 28:103011. doi: 10.1016/j.ctim.2023.103011. Online ahead of print.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2022
• Primary Completion (Actual): July 9, 2022
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: meditation; microbiome; arhatic yoga; beneficial microbes
• Other Study ID Numbers: PHRI-2022-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Share the study protocol as well as raw data generated for amplicon sequencing
• IPD Sharing Time Frame: After publication, raw amplicon data will be available in NCBI for a very long time
• IPD Sharing Access Criteria: Bioproject ID from NCBI will be described in publication. Researchers can use that ID and download or see the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No