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

NCT06306469 | Completed

• 1 other identifier: PHRI-2022-1001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy

Keywords

microbiome; meditation; arhatic yoga; beneficial microbes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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 .

Other: Meditation practice

Interventions

Meditation practice OTHER

physical and breathing exercises

single Arm1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• concomitant disease that requires any medical treatment
• pregnancy
• any antibiotic treatment in the past two weeks
• pediatric population
• clinical apparent infectious disease

Sponsors & Collaborators

• Pranic Healing Research Institute: lead

Study Sites (1)

Pranic Healing Research Institute

Lyndhurst, New Jersey, 07071, United States

Location

Related Publications (3)

• 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.

  PMID: 38307809 BACKGROUND

• 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.

  PMID: 37020274 BACKGROUND

• 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.

  PMID: 29306937 BACKGROUND

Study Officials

• Glenn Mendoza

  Pranic Healing Research Institute,New Jersey, 07071, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: July 2, 2022
• Primary Completion: July 9, 2022
• Study Completion: January 11, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publication, raw amplicon data will be available in NCBI for a very long time
• Access Criteria: Bioproject ID from NCBI will be described in publication. Researchers can use that ID and download or see the data.

Locations

US (1)