Clinical trial NCT06306469: Changes in Microbiota in Healthy Subjects Before and After Meditation Practices in a Controlled Environment
Official title: Changes in Microbiota and Biochemical Markers in Healthy Subjects Before and After Meditation Practices in a Controlled Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: microbiome
meditation
arhatic yoga
beneficial microbes
Lead sponsor: Pranic Healing Research Institute
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing the changes in gut and oral microbiome profile of the participants during retreat
timeFrame: Timepoint1: 1 day (Baseline), Timepoint2: 3-5 days, and Timepoint3: 7-9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyndhurst
country: United States
facility: Pranic Healing Research Institute
state: New Jersey
Study officials:
affiliation: Pranic Healing Research Institute,New Jersey, 07071, USA
name: Glenn Mendoza
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.