Effects Of Meditation On The Gut Microbiome And Human Health and Disease
Conditions: Amyotrophic Lateral Sclerosis (ALS), Angina, Stable, Anxiety, Asthma, Atrial Fibrillation, Cancer Brain, Cancer, Breast, Cancer Colon, Cancer, Lung, Cancer, Ovarian, Cancer Prostate, Cancer Skin, Throat Cancer, Lymphoma, Cancer, Thyroid, Cancer, Other, Cerebral Palsy, Chronic Fatigue Syndrome, Cluster Headache, Chronic Obstructive Pulmonary Disease (COPD), Chronic Kidney Diseases, Crohn Disease, Deafness, Depression, Diabetes, Eczema, Epilepsy, Fibroids, Fibromyalgia, Heart Failure, Hypertension, Hyperthyroidism, Hypothyroidism, Irritable Bowel Syndrome (IBS), Infertility, Lyme Disease, Macular Degeneration, Migraine, Multiple Allergies, Multiple Sclerosis, Osteoarthritis, Osteoporosis, Ovarian Cysts, Parkinson Disease, Phantom Limb Pain, Psoriasis, Post Traumatic Stress Disorder (PTSD), Rheumatoid Arthritis, Sjogrens Disease, Spinal Cord Injury, Spinal Stenosis, Stroke, Tension Headache, Tinnitus, Ulcerative Colitis
Sponsor: Tobias Moeller-Bertram

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Effects of 
Meditation on Human Well-being and Function 
 
 
 
Clinical Protocol 
Protocol # MED02 
April 2021 
Version 1.0 
 
 
 
 
 
 
Principal Investigator: Dr. Tobias Moeller-Bertram 

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Table of Contents 
Signature Page 
1 
List of Abbreviations 
5 
1 Background/ Significance 
6 
2 Objectives 
7 
3 Potential Risks 
8 
3.1 Risk Management 
8 
3.2 Potential Benefits 
9 
3.3 Risk/Benefit Assessment 
9 
4 Eligibility 
4.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
9 
4.1.1 Inclusion Criteria 
9 
4.1.2 Exclusion Criteria 
9 
4.2 Experiment B (Measuring the effects of meditation on the human organism) 
10 
4.2.1 Inclusion Criteria 
10 
4.2.2 Exclusion Criteria 
10 
4.3 Experiment C (Measuring the effects of meditation within the meditation community) 
11 
4.3.1 Inclusion Criteria 
11 
4.3.2 Exclusion Criteria 
11 
4.4 Subject Withdrawal / Discontinuation 
11 
4.5 Subject Compensation 
11 
4.6 Alternatives to Participation 
11 
5 Subject Recruitment 
11 
6 Study Design and Procedures 
12 
6.1 Study Procedures 
6.1.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
12 
6.1.2 Experiment B (Measuring the effects of meditation on the human organism) 
12 
6.1.3 Experiment C (Measuring the effects of meditation within the meditation 
community) 
12 
6.2 Timeline 
12 
6.2.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
12 
6.2.2 Experiment B (Measuring the effects of meditation on the human organism) 
12 
6.2.3 Experiment C (Measuring the effects of meditation within the meditation 
community) 
14 

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6.3 Experimental Protocol 
14 
6.3.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
14 
6.3.2 Experiment B (Measuring the effects of meditation on the human organism) 
15 
6.3.3 Experiment C (Measuring the effects of meditation within the meditation 
community) 
16 
6.4 Electroencephalography (EEG) and QEEG 
17 
6.4.1 EEG and QEEG - Procedure Details 
17 
6.4.2 EEG and QEEG - NeuroField q21 device details 
17 
6.4.3 EEG and QEEG - BrainMaster device details 
17 
6.5 Heart Rate Variability (HRV) and Wearables 
18 
6.5.1 Heart Rate Variability (HRV) Procedure Details 
19 
6.5.2 Heart Rate Variability (HRV) Firstbeat Bodyguard 2 (BG2) device details 
19 
6.5.3 Hearth Rate Variability (HRV) EmWave software details 
20 
6.5.4 Wearables 
20 
6.6 Laboratory work 
20 
6.7 Biospecimen Handling and Storage 
21 
6.7.1 Saliva Collection and Handling 
21 
6.7.2 Blood collection and Handling 
21 
6.7.3 Biospecimen Storage 
21 
6.8 FLIP Video/ Audio Capture 
21 
7 Data Collection and Management Procedures 
22 
8 Data Analysis 
22 
9 Quality Control and Quality Assurance 
22 
10 Statistical Analysis 
22 
11 Regulatory Requirements 
23 
11.1 Informed Consent 
23 
11.2 Subject Confidentiality 
23 
11.3 Unanticipated Problems / SAEs 
23 
12 Funding 
23 
13 Conflict of Interest 
23 
14 Qualifications and Training 
23 
15 Appendices 
24 
15.1 Informed Consent 
24 
15.2 Demographics Questionnaire 
24 
15.3 Medical History Template 
24 

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15.4 PROMIS-29 Questionnaire 
24 
15.5 MEQ 30 Questionnaire 
24 
15.6 FirstBeat Fitting Cheatsheet 
24 
15.7 Daily HRV Log Template 
24 
15.8 FirstBeat - Technologies - BodyGuard 2 
24 
15.9 Coherence Healing Questionnaire 
24 
15.10 GAD-7 
24 
15.11 MSQ Questionnaire 
24 
15.12 PEG 3 
24 
15.13 PSS 
24 
15.14 Perma Profiler 
24 
15.15 PHQ-9 
24 
15.16 PANAS 
24 
15.17 Primal World Survey 
24 
15.18 SF-36 
24 
15.19 PCL-5 
24 
15.20 BPI 
24 
16 References 
25 

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Signature Page 
 
The signature below constitutes the approval of this protocol and the attachments and 
provides the necessary assurances that this study will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH GCP guidelines. 
 
Site Investigator:* 
 
 
Signed: 
 
 
Date: 
 
 
Name/Title 
 
 
 
 
 
 
* The protocol should be signed by the clinical site investigator who is responsible for 
the day-to-day study implementation at his/her specific clinical site. 

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List of Abbreviations 
EEG - Electroencephalogram 
ECG - Electrocardiogram 
GCP - Good Clinical Practices 
ICH - International Council Harmonization 
IRB - Institutional Review Board 
COI - Conflict of Interest 
Q&A - Question and Answer 
PST - Pacific Standard Time 
HRV - Heart Rate Variability 
RCH – Remote Coherence Healing 

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1 Background/ Significance 
This submission of MED02 is an extension of the currently approved protocol MED01 
#1273003. Under this new protocol, we want to expand explorative data collection to cover two 
new areas of interest. One area is to collect pilot data on coherence healing (outlined in 
experiment A). Under this paradigm, meditators (Healers) utilize meditation to facilitate healing 
of a person (Healee). 
The second area expands pilot data collection to Dr. Joe Dispenza’s meditation community, 
independent from specific meditation events (outline in experiment C). Lastly, this new protocol 
builds upon the ability of collecting data during an event (outlined in experiment B). 
 
Meditation has been used by cultures across the globe for millennia. In Eastern religions, 
meditation is common and has its roots in Hindu and Buddhist traditions and manuscripts dating 
back hundreds of years after Buddha’s death.1 Additionally, effects similar to meditation have 
also been described in Muslim2 and Christian prayers, as well as spiritual reflection and 
chanting, suggesting that these practices are an integral part of human culture and existence.1,3 
In recent years, meditation as a therapeutic option and lifestyle choice has become increasingly 
popular in Western cultures. A paradigm shift is emerging in evaluating the relationship between 
spirituality and medicine. This shift is reflected by the increase in medical publications in the 
PubMed database containing the search term ‘meditation’. Until the year 1970, below 2.2 
manuscripts per year were published that contained this term. This average number increased 
by two orders of magnitude in recent years with an average of 26.4 between 1971 and 2000 and 
244.6 from 2001 until present. Our specific interest is to establish and describe the molecular 
relationship between mind and body.1 
 
Current manuscripts investigate several effects of meditation on human biology and pathology. 
Specifically, there is an emphasis on stress reduction and utilization of meditation as an adjunct 
treatment in chronic pain4,5 and neuropsychiatric diseases such as anxiety and depression6,7, 
sleep disorder8,9, and post-traumatic stress disorder.10 For example, the following molecular and 
physiological effects of meditation are described. In a study investigating inflammatory 
biomarkers in inflammatory bowel disease, psychological and physical symptoms as well as C- 
reactive protein were significantly reduced in a group that participated in a Breath-Body-Mind 
Workshop.11 Another study investigated telomere biology in attendees of a 1-month long 
meditation event and concluded that training in an event setting may have effects on telomere 
regulation.12 Cortisol is a biomarker that has been shown to be positively influenced in subjects 
practicing mindfulness.9 Furthermore, influences of meditation on the heart-brain connection13,14 
and the epigenetic clock15 have also been described. 
 
Several studies have investigated brain waves measured with electroencephalography (EEG) in 
meditators and have looked at different meditation techniques. In one study investigating 
Vipassanna meditators, differences in brain wave recordings were found between novice, 
experienced senior and teacher meditators.16 In Brahma Kumaris Raja yoga meditators it has 
been shown that experienced meditators can shift reliably and consciously between rest and 
meditation with enhanced theta power (4-8Hz).17 Furthermore, an increased brain network 
integration and long-lasting changes in hippocampal functional topology during resting states 
have been described and associated with meditation.18,19 

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Popularity of Complementary and Alternative Medicine (CAM) such as Yoga, Tai Chi, Qi Gon, 
and meditation has been rapidly increased and many patients in all the world use spiritual 
healing and other CAM practices.20 Spiritual actions and spirituality are intrinsic identities of 
humanity and potential healing forces.21 
 
Given this wide variety of studies and techniques and the positive effects of meditation and 
mindfulness practices, well-controlled studies are difficult to perform in everyday settings. 
Furthermore, studies aiming to phenotype the meditative state and integrating read-outs 
evaluating behavior, physiology, and molecular biology are currently not available. Studies 
examining specific known end points have been conducted but introduce bias and are ultimately 
limited in their scope. Limited investigations have approached the mind:body:molecular 
connection in an unbiased manner to identify novel and unique markers.Studying a community 
using the same meditation principles and practice will allow to control for a lot of the above 
mentioned difficulties in studying meditation. In addition, nan event setting here poses the 
unique situation that matching/controlling for several parameters such as housing, diet, climate, 
circadian pattern, and daily routine is possible additionally to matching in parameters such as 
gender, age, and body mass index. This provides a rare opportunity for a very well-controlled 
pilot study to explore and ultimately phenotype meditative state in the human organism. 
 
2 Objectives 
 
The objective of this study is to describe the effects of meditation on human well-being and 
function and to learn in greater detail what effect meditation has on the human organism. We 
are proposing experiments exploring three areas of interest (experiments A, B, C) utilizing 
procedures, including bio-psychosocial readouts, physiologic, and biologic/molecular 
measurements. We therefore propose a combination of different experimental components, as 
follows: 
 
Experiment A: Measuring the effects of meditation on the Healer and Healee. Healers include 
members of Dr. Joe Dispenza’s mediation community who participate in a healing event. 
Healees may include individuals who volunteer to receive a healing and may or may not be 
members of the Dr Joe Dispenza meditation community 
 
Experiment B: Measuring the effects of meditation on the human organism. Here, we are 
interested in collecting data before, during, and after a meditation event (intervention) held by 
Dr. Joe Dispenza. We will compare Dr Joe meditators to controls and to meditators following 
other forms of meditation, including but not limited to mindfulness-based techniques, relaxation 
response, breath-based techniques, and prayer. 
 
Experiment C: Measuring the effects of meditation within the meditation community. Here we 
are interested in collecting data from members of Dr. Joe Dispenza’s meditation community on 
human well-being and function. 
 
Particularly, we are interested in collecting the following data: 

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1. Questionnaire data (i.e. demographics, medical history, PROMIS measures) 
2. Physiological readouts (i.e heart rate variability {HRV}, Electroencephalogram {EEG} 
and physiological readouts from wearables like FitBit, Garmin or Apple Watch) 
3. Biological data (i.e blood, plasma, serum, and saliva) 
4. FLIP Video Capture (record a 1.5-3 min video at the end of each day of the meditation 
retreat reflecting on their experiences) 
 
We are hoping to contribute significantly to the understanding of the effects of meditation on 
human well-being and function and to establish a meditation whole-organism phenotype. 
 
We propose the following aims: 
 
Aim 1: Explore effects of meditation on Healer, Healee and their interactions. 
 
Aim 2: Evaluate and/or correlate brain waves (EEG) and physiological readouts (HRV, wearable 
data) of meditating subjects with their experience in meditation techniques including novice (less 
than 6 months experience) and experienced meditators (more than 6 months experience). 
 
Aim 3: Explore potential effects of meditation on molecular biology (e.g. biomarker and -omic 
changes) between novice and experienced meditators and controls. 
 
Aim 4: Explore correlation between EEG state, HRV, wearable readouts, and molecular 
findings. 
 
3 Potential Risks 
 
3.1 Risk Management 
This study is anticipated to have minimal risk to subject safety. 
Questionnaire: 
The data collection, including demographic data, will be done by approved study personnel 
using paper or electronic format. For paper collections, all information will be de-identified and 
kept under double-secured filing systems. For electronic collections, we will be using HIPAA 
compliant software (i.e. SurveyMonkey, CRIO). Data will be de-identified and stored 
electronically in a password protected database. Access to the database will be restricted to 
key personnel of this study. As with all electronically stored data, a breach of security is a 
potential risk. 
HRV / Wearable Recordings: 
The HRV recording equipment is similar to recording a standard 3-lead ECG. Skin reactions to 
adhesives in the electrode are a theoretical risk. All wearable equipment is commercially 
available and cleared. 
EEG Recordings: 
During recording of the EEG, slight headaches in very sensitive individuals may occur. If 
wearing the EEG equipment on the head cannot be tolerated, the sampling procedure can be 
stopped immediately. Furthermore, a skin reaction to the electrode adhesive is theoretically 

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possible. 
Biologicals: 
Drawing blood always poses a risk of infection and mild discomfort. These will be mitigated by 
having the blood draws performed by experienced professionals using standard techniques. 
Saliva collections utilize non-invasive techniques. Collections of this data pose no additional 
risk. 
 
3.2 Potential Benefits 
There will be no direct benefits to participants in this study from the study procedures. However, 
the data obtained will contribute to future research into the molecular effects of meditation 
practices. 
 
3.3 Risk/Benefit Assessment 
The risks of participation are minimal and are offset by the value of the information obtained. 
 
 
4 Eligibility 
Since we propose to look at different cohorts under this protocol, as outlined under Experiment 
A, B, C, we will follow the same format for Inclusion/Exclusion Criteria. 
 
4.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
 
4.1.1 Inclusion Criteria 
Potential subjects must meet all inclusion criteria: 
1. Subjects must be a participant in a Dr. Joe Dispenza healing event to qualify as a 
Healer. 
2. Subject must volunteer to receive a healing in a Dr. Joe Dispenza healing event to 
qualify as a Healee. 
3. Subject or an assigned representative must be willing and able to read and provide 
Informed Consent in English language. 
4. Subjects must be 18 years of age or older. 
 
4.1.2 Exclusion Criteria 
Potential subjects must not meet any exclusion criteria: 
1. Unable or unwilling to provide Informed Consent. 
2. Subjects with any medical condition that by discretion of the Principal Investigator would 
be disqualified. 

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4.2 Experiment B (Measuring the effects of meditation on the human organism) 
 
 
4.2.1 Inclusion Criteria 
Potential subjects must meet all inclusion criteria: 
1. 
Subjects must be 18 years of age or older. 
2. 
Subjects must be a participant in a Dr. Joe Dispenza meditation event. 
3.  Subject or an assigned representative must be willing and able to read and provide 
Informed Consent in English language. 
Potential controls must meet all inclusion criteria: 
1. Controls must be 18 years of age or older. 
2. Controls must be willing and able to read and provide Informed Consent in English 
language. 
 
4.2.2 Exclusion Criteria 
Potential subjects must not meet any exclusion criteria: 
1. Neurological diagnosis that could interfere/alter with EEG recordings such as epilepsy. 
2. Subjects who had a heart transplant. 
3. Subjects who have cardiac disease that could interfere with ECG recording such as but 
not limited to cardiac arrhythmia or disorder of cardiac conduction. 
4. Subjects who have been diagnosed with a malignant disease that could interfere with 
blood parameters. 
5. Subjects with any medical condition that by discretion of the Principal Investigator would 
be disqualified. 
Potential controls must not meet any exclusion criteria: 
1. Neurological Diagnosis that could interfere/alter with EEG recordings such as epilepsy. 
2. Controls who had a heart transplant. 
3. Controls who have cardiac disease that could interfere with ECG recording such as but 
not limited to cardiac arrhythmia or disorder of cardiac conduction. 
4. Controls who have been diagnosed with a malignant disease that could interfere with 
blood parameters. 
5. Controls with any medical condition that by discretion of the Principal Investigator would 
be disqualified. 
6. Controls must not be a participant in a Dr. Joe Dispenza meditation event. 

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4.3 Experiment C (Measuring the effects of meditation within the meditation 
community) 
 
4.3.1 Inclusion Criteria 
Potential subjects must meet all inclusion criteria: 
1. Subjects must be a member of Dr. Joe Dispenza meditation community. 
2. Subject must be willing and able to read and provide Informed Consent in English 
language. 
3. Subjects must be 18 years of age or older. 
 
4.3.2 Exclusion Criteria 
Potential subjects must not meet any exclusion criteria: 
1. Unable or unwilling to provide Informed Consent. 
2. Subjects with any condition that by discretion of the Principal Investigator would be 
disqualified. 
 
4.4 Subject Withdrawal / Discontinuation 
Subjects have the ability to withdraw from the study at any point. Data collected prior to the 
withdrawal of consent will be stored and potentially used in data analysis. 
Subjects may also be discontinued from participating if the Investigator has reason to believe 
that they are not adhering to study requirements. 
 
4.5 Subject Compensation 
• Research subjects will not be compensated for participation in these studies. 
• Research controls may receive a modest form of compensation for participation in these 
studies. 
 
4.6 Alternatives to Participation 
The alternative to participating in this research study is to not participate in the research study. 
Patients will receive no different treatment at the meditation event if they choose not to 
participate. 
 
5 Subject Recruitment 
Subject outreach will utilize Dr. Joe Dispenza’s online presence (website, social media, etc.). 
Subjects will be recruited through prescreening emails to members of Dr. Joe Dispenza 
meditation community and/or registered event participants. These emails will briefly explain the 
research study and offer the subject the option to follow a link for pre-screening. 
For pre-screening, potential subjects will visit a pre-screening questionnaire via a HIPAA 
compliant software (ie. SurveyMonkey) and be asked general pre-screening questions based on 

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the inclusion and exclusion criteria. The questionnaire will also collect basic data such as 
demographics and past medical history. 
 
6 Study Design and Procedures 
 
6.1 Study Procedures 
 
6.1.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
Our exploratory study will focus on interactions among Healers and Healees. We are also 
interested in collecting data among Healers themselves. 
 
6.1.2 Experiment B (Measuring the effects of meditation on the human organism) 
Under this paradigm, we will collect data on the effects of meditation on the human organism. 
We therefore aim to collect data before, during, and after a meditation event that take place 
nationally and internationally on a regular basis. The environment of an event poses the rare 
opportunity of minimized confounding factors (i.e. diet, housing, sleep). 
 
6.1.3 Experiment C (Measuring the effects of meditation within the meditation community) 
Under this exploratory paradigm, we are interested in collecting data within members of Dr. Joe 
Dispenza’s meditation community. Given the large size and diversity of this global community, 
practicing the same meditative practice, we will be able to generate a set of interesting pilot 
data. 
 
6.2 Timeline 
 
6.2.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
For qualifying subjects, consenting as well as data collection will be performed electronically 
prior to the event. For both Healers as well as Healees, we will collect a set of baseline 
measures, including demographics, medical history, and questionnaire data. 
The baseline will be collected in a timeframe after consenting but before the first healing event. 
After the healing event, we will collect outcome date at different timepoints (i.e. immediately 
after healing event, 1, 3, 6, 9, 12 months out). These data will be collected electronically. If 
baseline data collection also included physiological and/or biological data, we may collect these 
follow-up data at the above time points as well. 
 
 
6.2.2 Experiment B (Measuring the effects of meditation on the human organism) 
The timeline, as outlined in Figure 1, is divided into pre-event, immediate pre-event, during 
event, immediate post-event, and post-event. 

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Pre-event: For qualifying subjects and controls, consenting as well as baseline data collection 
will be performed electronically prior to the event. 
 
 
Immediately pre-event: The data collection is organized into 4 stations. 
Station 1: 
• 
Confirming of consenting and baseline data (for those who did not use online option, 
consenting and baseline data will be done.) 
• 
Vitals 
Station 2: 
• 
Physiological data (i.e. HRV, wearables) 
Station 3: 
• 
Physiological data (i.e. EEG) 
Station 4: 
• 
Biological data (i.e. saliva, blood) 
 
During the event: Data collection during the event may include additional collection of 
questionnaire data, physiological data, and biological data. 
 
Immediately post-event: The data collection is organized into 4 stations. 
Station 1: 
• 
Vitals 
• 
Questionnaire data 
Station 2: 
• 
Physiological data (i.e. HRV, wearables) 
Station 3: 
• 
Physiological data (i.e. EEG) 
Station 4: 
• 
Biological data (i.e. saliva, blood) 
 
Post-event: follow-up data may be collected electronically. Time points may include 1,3, 6, 9, 12 
months post-event. If baseline data collection also included physiological and/or biological data, 
we may collect these follow-up data at the above time points as well. 

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Figure 1: Timeline 
 
 
6.2.3 Experiment C (Measuring the effects of meditation within the meditation community) 
In this exploratory paradigm, we will include studies collecting data among Dr. Joe Dispenza’s 
meditation community. We will focus on gathering pilot data (i.e. questionnaires and wearable 
data) of long term effects of meditation on human well-being and function. The duration may 
span from several weeks to several months. 
 
6.3 Experimental Protocol 
 
6.3.1 Experiment A (Measuring the effects of meditation on the Healer and Healee) 
Subject selection: 
Healer: Members of Dr. Joe Dispenza’s meditation community who meet inclusion/exclusion 
criteria qualify to participate. Depending on the healing event, we anticipate recruiting between 
10 to 100 Healers. 
For Healers, consenting as well as baseline data collection will be performed electronically prior 
to the event. The consent form will be provided to the selected Healers for review. The PI or 
designated research staff member will go over the consent form in person or via HIPAA 

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compliant web meeting platform (ie. Zoom). During this time, Healers will have ample time to 
have all questions and concerns addressed. We may also collect baseline measures including 
physiological readouts (i.e. wearables, HRVs) and/or biological data (i.e. saliva). During the 
healing event, we may collect physiological readouts (i.e. EEG, HRV), biological data (i.e. 
saliva) and questionnaire data. After the healing event, follow-up data will be collected 
electronically. Time points may include immediately after, 1,3, 6, 9 12 months post event. If 
baseline data collection also included physiological and/or biological data, we will collect these 
follow-up data at the above time points as well. 
Healee: A list of Volunteers who are interested in participating in a healing event will be 
provided by Dr. Joe Dispenza’s staff. From that list, participants who meet the 
inclusion/exclusion criteria will be recruited: we anticipate recruiting up to 100 to 150 
participants. 
For Healees, consenting as well as baseline data collection will be performed electronically prior 
to the event. The consent form will be provided to the selected Healees for review. The PI or 
designated research staff member will go over the consent form via HIPAA compliant web 
meeting platform (ie. Zoom). During this time, Healees will have ample time to have all 
questions and concerns addressed. We may also collect baseline measures including 
physiological readouts (i.e. wearables, HRVs) and/or biological data (i.e. saliva). Immediately 
prior to the healing event, Dr. Joe Dispenza guides the Healees through a meditation to prepare 
them for the healing event. During the healing event, Healees will listen to music. After the 
healing event, follow-up data will be collected electronically. Time points might include 
immediate after, 1,3, 6, 9 12 months post event. If baseline data collection also included 
physiological and/or biological data, we will collect these follow-up data at the above time points 
as well. 
 
 
6.3.2 Experiment B (Measuring the effects of meditation on the human organism) 
Subject selection: Pre-event, registered participants Dr. Joe Dispenza’s event will be contacted 
(i.e. email) and made aware of the research opportunity. Registered participants who are 
interested will be able to follow a link to a pre-screening questionnaire. Members of Dr. Joe 
Dispenza’s meditation community who pass pre-screening qualify to participate. Depending on 
the event, we anticipate recruiting between 10 to 100 subjects. 
Control Selection: In addition, we will identify controls by asking participants if they are traveling 
with family/friends who will be at the event but will not participate in the event; these may be 
volunteers of the event, and/or family/friends of meditators participating in the event. Controls 
will be age and sex matched to match subjects. We anticipate recruiting between 5 and 20 
control subjects. The consenting as well as some baseline data (i.e. Medical history, 
demographics) collection will be performed electronically prior to the event. 
Pre-event: Consenting: The consent form will be provided to the selected subjects for review 
prior to the event. The PI or designated research staff member will go over the consent form in 
person or via HIPAA compliant web meeting platform (i.e. Zoom). During this time, subjects will 
have ample time to have all questions and concerns addressed. We may also collect baseline 

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measures including physiological readouts (i.e. wearables, HRVs) and/or biological data (i.e. 
saliva). 
Immediate Pre-event: Confirming of consent and baseline data (for those who did not use online 
option consenting and baseline data will be done). Vitals (i.e. height, weight, heartrate, 
temperature, blood pressure), physiological data (i.e. HRV, EEG, wearables), and biological 
data (i.e. saliva, blood) will be collected from all consented subjects and controls. 
During event: Data collection during the event may include additional collection of questionnaire 
data, physiological data and biological data. 
Immediate post-event: Vitals (i.e. height, weight, heartrate, temperature, blood pressure), 
physiological data (i.e. HRV, EEG, wearables), and biological data (i.e. saliva, blood) will be 
collected from all consented subjects and controls. 
Post event: Follow-up data may be collected electronically. Time points may include 1, 3, 6, 9, 
12 months post-event. If baseline data collection also included physiological and/or biological 
data, we may collect these follow up data at the time points above as well. 
 
6.3.3 Experiment C (Measuring the effects of meditation within the meditation community) 
We will be collecting data among Dr. Joe Dispenza’s meditation community. We will focus on 
gathering pilot data (ie. Questionnaires and wearable data) on long term effects of meditation on 
well-being and function. Duration may span from several weeks to several months. Data 
collection time points may include baseline, 1, 3, 6, 9, 12 months post event. 
 
6.4 Electroencephalography (EEG) and Quantitative electroencephalography 
(QEEG) 
 
Electroencephalography (EEG, from Greek encephalon brain, writing graphs) is a method of 
medical diagnostics and neurological research for measuring the summed electrical activity of 
the brain by recording the voltage fluctuations at the head surface. The electroencephalogram is 
the graphical representation of these variations in the typical waveform. The EEG is a standard 
method used in neurology. 
 
Quantitative electroencephalography is a further development that allows further conclusions 
regarding disorders by means of IT-technical procedures of the EEG data. In essence, here the 
amplitudes of frequencies are measured by means of the fast Fourier transform and set in 
relation to each other. 
 
The QEEG data is intended to describe the change in brain activity and arousal for each 
participant. 
 
For the analysis and data collection, three different arousal states will be recorded before and 
after the event. State 1 records the QEEG with eyes open without meditation/audiobook, state 2 
records QEEG with eyes closed but without meditation/audiobook, and state 3 records QEEG 
with eyes closed listening to a short pre-recorded meditation by Dr. Joe Dispenza or a section of 

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an audiobook. All participants are instructed to sit as still and calm as possible to avoid artifacts. 
Participants will be filmed to allow for potential artifact tracking. 
 
We will be utilizing two different EEG device manufacturers (details follow under 6.4.2 and 
6.4.3) 
 
6.4.1 EEG and QEEG – Procedure Details 
 
Immediate Pre-event and Immediate Post-event procedure: We will measure brainwave data 
and acquire six recordings per participant. 
Subjects: The subjects will be listening to a pre-recorded meditation from Dr. Joe Dispenza. 
Measurements will take place with eyes open, and eyes closed (one set as baseline before pre- 
recorded meditation, one set during pre-recorded meditation, and possibly one set after pre- 
recorded meditation). 
Controls: The controls will be listening to a section of an audio book. Measurements will take 
place with eyes open, and eyes closed (one set as baseline before pre-recorded audio book, 
one set during pre-recorded audio book, and possibly one set after pre-recorded audio book). 
During event: EEG recording procedure details: Prior to a meditation happening during the 
event, some subject’s EEG may be measured. Following above outlined details, subjects will be 
fitted with the EEG cap. The subject will meditate, and the EEG will be recorded for the duration 
of the meditation. 
 
6.4.2 EEG and QEEG – NeuroField Q21 device details 
 
To obtain the EEG, subjects will be fitted with a 19+1 channel Q21 DC coupled EEG amplifier. 
(Channel: 19+1 (Non-Multiplexed). References: A1/A2 (ears). Ground: Channel 20. Input 
Range: +/- 100mV EEG, +/-5 VDC. Input noise: 0.25 V P-P, 0.1-10.0Hz. Gain: 50. Common 
Mode Rejection Ratio: >120dB from 0-60Hz. Single Pole Low Pass Filter: ~80Hz. Resolution: 
24 bits. Sample Rate/Data Rate: +/-2.25 V. EEG Resolution: 0.02 Volts/LSB. EEG Channels 
Bandwidth: Software Controllable. DC Offset Measurement: Average DC Level. Sensor 
Contact Quality: Monitoring Via Offset Voltage. PC Connection: USB – CAN Optically Isolated. 
Software Compatibility: NeuroField64 & Neuroguide) 
 
The Q21 is fast, quiet and accurate. When used with NeuroField EEG the amplifier can 
measure data from 0-128 Hz in real time. This amplifier acquires EEG in 21 analog to digital 
pipes (each channel has its own dedicated analog to digital conversion, thus avoiding the slew 
found in amplifiers using multi-duplex switching.) We may also collect event related potentials 
using NeuroField ERP which is a visual and auditory GO NOGO matching task, used to 
determine reaction time and processing speed, before and after the event. 
 
6.4.3 EEG and QEEG – BrainMaster device details 
 
To obtain the EEG, subjects will be fitted with a 19 channel cap (COMBY EEG CAP, Pamel, hr 
) according to the International 10/20 System with linked ear montage (Fp1, Fp2, F7, F3, Fz, 

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F4, F8, T3, C3, Cz, C4, T4, T5, P3, Pz, P4, T6, O1, and O2). COMBY EEG Caps are 
manufactured with gold plated electrodes and electrodes made from sintered silver chloride 
(Ag/AgCl), which are currently most suited for brain bio potential detection. They have low 
impedance and auto-potential. Their quality is reflected in excellent selectivity and stability. The 
EEG recordings will be recorded using BrainAvatar 4.6.4 software (BrainMaster Technologies, 
Inc, Bedford, OH). BrainAvatar incorporates technology including BrainMaster’s Discovery 
hardware devices, extensive signal processing and graphics software, and an exclusive high- 
speed sLORETA (standardized low-resolution electromagnetic brain tomography) voxel 
processor and 3D image projector. BrainAvatar is a full-featured clinically useful system, 
registered with the US FDA (https://www.brainmaster.com/kb-entry/?id=559) for professional 
clinical use, clinical EEG device, for neurological use and with a CE mark in Europe as a 
medically qualified biofeedback, monitoring, and imaging system. 
 
The EEG signals are then imported into the NeuroGuide v2.9.1 software (Applied Neuroscience, 
Inc., Largo, FL) for computation and analysis. Data will be visually inspected and artifacts (i.e., 
activity collected from the EEG not produced by the brain) removed. The EEG will be processed 
with linked ear montage and compared 
with the NeuroGuide normative database, and Z- 
scores will be obtained. For analysis, particular attention will be given to alpha and theta 
amplitudes. Specifically, increased frontal theta and low alpha, increased gamma and increased 
alpha and theta coherence are scientific correlates for meditative states and of interest. 
 
NeuroGuide software (Applied Neuroscience ) is an FDA Registered Database of Normative 
qEEG Values (510(K) Number K041263). It is a computer program that can compare the qEEG 
values of a given patient to the normative database and comparative produce brain maps. 
 
Data will be averaged for the analysis across the recording epochs for each electrode (LE 
montage - Fp1, Fp2, F7, F3, Fz, F4, F8, T3, C3, Cz, C4, T4, T5, P3, Pz, P4, T6, O1, and 
O2) to get the results of the absolute power (percentage of total power), power ratios (Ratio of 
the difference Frequency bands) and coherence (functional connectivity in human cortex, 
measuring between each electrodes). 
 
6.5 Heart Rate Variability (HRV) and Wearables 
Heart rate variability (HRV) is a measure of the naturally occurring beat-to-beat changes in heart 
rate/heart rhythms. It serves as a critical method for gauging human health and resiliency. HRV 
is a powerful, objective and noninvasive tool to explore the dynamic interactions between 
physiological, mental, emotional and behavioral processes. Researchers use HRV, as 
measured by an electrocardiogram (ECG) or pulse wave recording, to assess the state of the 
autonomic nervous system (ANS), which controls heart and breath rates, gastrointestinal tract 
movement and gland secretion among other internal bodily functions. Analysis of heart rhythm 
patterns also can provide an objective measurement of physiological coherence, a term that 
describes a state of high performance characterized by harmony in the body’s oscillatory 
systems. 

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6.5.1 Heart Rate Variability (HRV) Procedure Details 
Applicable to experiments A, B, & C: 
Subjects participating in HRV data collection will receive in-person or online training by the PI or 
designated research staff on using the HRV device and will be provided with written instructions 
(see submitted appendix 6). In addition, for each day where HRV is collected, the subjects will 
provide brief information (i.e. time they went to bed, activity level, device pop-ups) (see 
submitted appendix 7) 
Experiment B: 
Immediate Pre-event and Immediate Post-event procedure: 
This 3-step HRV assessment protocol will be performed on subjects: 
1. Resting HRV assessment (5 minutes): Reflective of baseline HRV and cardiac 
coherence status 
Participant instructions: Please sit quietly for the next 5-minutes without talking, try to 
remain as still as possible without sacrificing comfort. Do not engage in intense 
mental or emotional activity. To help avoid falling asleep keep your eyes open. Do 
not meditate or use other similar practices. Just sit quietly as if you were wanting at 
the bus stop for the bus. (No gum chewing, or reading magazines etc.) 
2. Stress Prep (3 minutes): Reflective of ability to self-regulate and induce heart 
coherence on demand. 
Participant instructions: During the next 3-minutes please do the following, as if you 
were preparing yourself mentally and emotionally for an important upcoming event or 
activity. Focus your attention in the center of your chest. Try and activate and 
experience a positive feeling such as care or appreciation for someone or some 
special place. 
3. Deep breathing assessment (1 minute): Reflective of vagal tone capacity 
Participant is guided with a visual to breathe as deeply as they comfortably can at 
the pace shown on the screen (5 sec in / 5 sec out i.e. resonant frequency 
breathing). 
 
During event: When collecting HRV data, the participants will be instructed to apply the HRV 
monitor at the beginning of the day. Propper fitting will be confirmed by research study staff. For 
multiple day data collections, the participants will receive new electrodes as needed. 
 
 
6.5.2 Heart Rate Variabiltiy (HRV) Firstbeat Bodyguard 2 (BG2) device details 
Materials and Supplies: Firstbeat Bodyguard 2 (BG2) wearable heart rate monitor. The BG2 
provides accurate data for HRV analysis with a sampling rate of 1000Hz. Once HRV data is 
collected, it will be uploaded to a PC using the FirstBeat Technologies utility program called 
Firstbeat Uploader. The ASCII-text file is emailed to HeartMath and analysis of the data is 

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performed using DADiSP 2002 software and Microsoft Excel. Visual inspection for the quality of 
the recording is made prior to generating the Autonomic Assessment Report which gives a 
detailed look at several HRV indices including SDNN, RMS-SD, HF, LF, VLF, as well as 
circadian sleep cycles. (see attached appendix 8) 
 
 
6.5.3 Heart Rate Variability (HRV) EmWave software details 
emWave® Pro Plus provides an easy way to inexpensively add standardized HRV measures to 
your research or practice with two heart rate variability assessments that can be added to the 
emWave Pro software. These assessments can be used in a wide range of applications such as 
quantifying HRV levels in relationship to autonomic capacity, determining changes in HRV or 
coherence levels in research studies or interventions, and documenting physiological baseline 
shifts over time. 
 
 
6.5.4 Wearables 
Commercially available wearables (i.e. FitBit, Garmin, Apple Watch) are able to record 
physiological data including HRV, skin conductance, temperature, etc. This non-invasive 
method of capturing physiological data may be added to the proposed experiments. 
For collection and analysis of wearable data, we also will utilize technology available through 
RAE Health. The first component of the RAE system is a wrist worn wearable sensor to 
continuously detect physiologic data, which are streamed continuously via Bluetooth connection 
to the RAE app. The current version of the app pairs with the Garmin Viosmart 4. The Vivosmart 
4 is equipped with a barometric altimeter, tri-axial accelerometer, heart rate monitor, and pulse 
oxygenation sensor. The Viviosmart 4 has a touch screen interface, has up to 7 days of battery 
life, and functions as a standard fitness tracker. 
The RAE mobile application is available for Android and iOS. Features of RAE app include 
geolocation based monitoring tools, and general health monitoring tools. 
 
6.6 Laboratory work 
Unbiased analysis of biological specimen: Serum, plasma, and saliva samples will be used for 
various assays that will examine changes in the biophysical properties of contents as well as the 
potential to assess the impact of the biospecimen on various assays of cell stress and 
metabolism. The overall approach to analyze the collected samples will be exploratory. The 
following assays are part of this approach. 
NanoSite characterization: We will use small amounts of plasma/serum (<100uL) to assess 
extracellular particle size and quantity. 
Electron Paramagnetic Resonance (EPR): We will use EPR to perform two assays. One will use 
specific lipid spin probes to assess changes in the membrane/lipid fluidity of particles floating in 
the plasma/serum. The second assay will measure ascorbyl radical as a global measurement 
of oxidative stress in a system. This value can be used to determine if there are whole body 
level changes in stress pre- and post- intervention. 

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Seahorse Metabolic Flux Assay: We will use plasma/serum to assess the impact of 
plasma/serum components on cellular effects on mitochondrial metabolism. We can assess 
these effects in a variety of different cell types that represent every organ in the human body. 
This can provide a non-invasive picture of what may be happening in cells pre and post 
treatment. 
Metabolomic analysis: We will assess standard and lipid metabolite changes in plasma/serum 
with a core facility at UC Davis. This will give an unbiased assessment of factors that may be 
changing pre and post treatment. The analysis can then correlate to other measurements made. 
Cell based assays: Measurements of cell death, apoptosis, growth, and changes in specific 
proteins will be performed. 
Additionally, we intent to analyze concentrations of hormones (i.e. Cortisol, Norepinephrine, 
Cytokine profile) and biomarkers of the human stress response in the biospecimen. 
 
6.7 Biospecimen, Collection, Handling and Storage 
6.7.1 Saliva collection and Handling 
The participants will be instructed not to eat or drink 30-45 minutes prior to specimen collection. 
Immediately prior to specimen collection, the participant is instructed to scrape inner cheek for 
10-20 motions, and then submit saliva into collection tubes. We will collect up to 4 mL of 
specimen each collection. We may mix saliva sample with stabilizer to preserve specimen. The 
saliva collection tubes will be handled by a trained research staff member using universal 
precautions. 
6.7.2 Blood Collection and Handling 
Blood will be collected by certified personnel utilizing universal precautions for venous puncture. 
Blood will be collected utilizing purple top EDTA tubes (10cc), red top serum tubes (6cc), or 
blood RNA tubes (2.5cc). Total amount of blood per collection will not exceed 30cc. The blood 
collection tubes will be handled by a trained research staff member using universal precautions. 
Purple top EDTA tubes will be placed on wet ice immediately after collection and then 
centrifuged at 3000RPM for 10 minutes. After centrifugation, the plasma from Purple top EDTA 
tubes will be aliquoted into 1mL Eppendorf tubes. Red top serum tubes will rest at room 
temperature for 30 minutes, and then centrifuged at 3000RPM for 10 minutes. After 
centrifugation, the serum from red top tubes will be aliquoted into 1mL Eppendorf tubes. RNA 
tubes will remain at room temperature. 
6.7.3 Biospecimen Storage 
Biospecimen (ie. Saliva, blood) will be processed and handled with universal precautions and 
stored at -80 degrees Celsius in a locked freezer. The freezer will be equipped with emergency 
power and access will be restricted. All samples will be blinded, coded, and the code will be 
stored in a separate location. 
 
6.8 FLIP Video/ Audio Capture 
 
Subjects will be provided with written instruction in which they will be asked to 1) download the 

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FLIP app onto their iPhone or Android device, 2) create a unique account in the app, and 3) 
record a 1.5-3 min video at the end of each day of the meditation retreat reflecting on their 
particular experiences. Following video capture, the videos will be transferred to an online 
database and identified using study subject numbers. Each subject will have access to only their 
own videos. Access to study subject videos will be restricted to two senior collaborators affiliated 
with UC San Diego. After video and audio content analyses are complete, the data will be erased 
from the database by the UC San Diego collaborators. 
Participants will be asked to record a short 1.5-3 minute video to describe their daily meditation 
experiences. Participants will be asked to download the FLIP app onto their cellular device to 
complete this recording. Data from these videos will allow us to assess personal transformation 
via verbal and body language at the end of each day and at the end of the retreat. 
 
7 Data Collection and Management Procedures 
Data collection will be performed through a HIPAA compliant software platform (i.e Clinical 
Research IO, a platform designed for Electronic Data Capture and eCRF development, or 
DropBox) 
 
8 Data Analysis 
Demographic characteristics will be analyzed by descriptive statistics. Survey data are collected 
on an ordinal 4-point or 5-point Likert scale and treated as continuous variables during analysis. 
The data is then analyzed to describe the distribution. If the data is normally distributed, we will 
follow up with utilizing parametric statistics. However, if the data does not follow a classic 
normal distribution, we will utilize other methods such as reporting the median instead of the 
mean for central tendency and further analyze our results with frequencies, contingency tables, 
chi-square-tests, Spearman rho assessment, or the Mann-Whitney U test. All other 
questionnaires will be analyzed according to published protocols. 
 
9 Quality Control and Quality Assurance 
To allow for high quality data collection, all study material will be pre-labelled whenever 
possible. During data collection days, a quality assurance person not directly involved in data 
collection will oversee the data collection process. The experimental protocol may include a full 
day for data collection set-up prior to data collection during the event This will assure that all 
necessary equipment is available and functioning. Once data is collected, standard data 
cleaning procedure will be applied, and data will be randomly audited. 
 
10 Statistical Analysis 
Data analysis will be organized by Vitamed Research LLC. Vitamed Research LLC. staff has 
10+ years of experience with statistical and data analysis. We will perform statistical analysis 
with appropriate parametric and non-parametric methods as described under Section 8. 

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11 Regulatory Requirements 
 
11.1 Informed Consent 
Informed consent will be obtained either electronically or in person following 21 CFR Part 11. 
Study procedures will be explained, and subjects will have the opportunity to have their 
questions and concerns addressed by PI or designated research study personnel. 
 
11.2 Subject Confidentiality 
Subjects will be de-identified and will be provided a subject number. All potentially identifiable 
information will be stored in a separate database and linked by a key. 
 
11.3 Unanticipated Problems / SAEs 
Any unanticipated problems will be reviewed by the investigator. If the investigator determines 
that the problem or SAE is related to the study protocol, the event will be reported to the IRB in 
adherence with standard protocol. 
 
12 Funding 
This project is funded through the Gift-to-Give foundation. 
 
 
13 Conflict of Interest 
There is no financial conflict of interest between PI Dr. Tobias Moeller-Bertram and Gift-To-Give 
foundation. We plan on utilizing some event staff (volunteers of Dr. Joe Dispenza) to assist in 
set-up, break-down, and flow of events. 
In addition, if any potential Conflict of Interest arises, it will be promptly reported to the IRB for 
review. If any COI is to arise without approval, the study will be reassigned to a new Principal 
Investigator. 
 
14 Qualifications and Training 
The investigator is triple board-certified MD and holds a Masters in Advances Science (MAS) 
Clinical Research. All Vitamed Research LLC. staff hold current training certificates in Good 
Clinical Practices. 

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15 Appendices 
1. Informed Consent 
2. Demographics Questionnaire 
3. Medical History Template 
4. PROMIS-29 Questionnaire 
5. MEQ 30 Questionnaire 
6. FirstBeat Fitting Cheatsheet 
7. Daily HRV Log Template 
8. FirstBeat – Technologies – BodyGuard 2 
9. Coherence Healing Questionnaire 
10. GAD-7 
11. MSQ Questionnaire 
12. PEG 3 
13. PSS 
14. Perma Profiler 
15. PHQ-9 
16. PANAS 
17. Primal World Survey 
18. SF-36 
19. PCL-5 
20. BPI 

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