Beneficial Exposome Study

Study Overview
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Brief Summary
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The purpose of this study is to explore the positive, holistic health outcomes resulting from regular exposure to naturally occurring compounds predicted to have health benefits. The researchers hope to learn how the human body is influenced by regular exposure to these compounds.

Detailed Description
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Considerable research has been conducted on the effects of environmental exposure on human diseases. This is also known as exposome research. However, there is limited research on the impact of beneficial exposomes found in the natural environment. The researchers would like to identify and measure the benefits of these naturally occurring compounds on holistic human health. Through blood specimens, the researchers will observe biomarkers such as cortisol levels and inflammatory markers. Data will be collected from wearable sensors to observe the effects of beneficial exposomes on areas such as cardiovascular health and sleep quality. There will be surveys to understand well-being, stress, and mood. Through such observations, this study aims to understand the positive impacts of intentional exposure to selected compounds found in nature.

Official Title
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Beneficial Exposome: Investigating Its Effect on Human Health

Conditions
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Healthy

Intervention / Treatment
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* Other: Natural Compound A (masked essential oil A)
* Other: Natural Compound B (masked essential oil B)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Read, speak, and understand English Live in the US territory Exclusion Criteria: Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol Is pregnant Is breastfeeding Has epilepsy Has allergies to Cupressaceae family of plants, common plants include redwoods, junipers, cypress, cedar, fir, and sequoia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will do the intervention but at different times and in different orders.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A- Natural Compound A to Natural Compound B<br>Cycle 1 (4 weeks): use diffused Natural Compound A (like an essential oil) in a diffuser every night when sleeping Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) Cycle 3 (4 weeks): use diffused Natural Compound B (like an essential oil) in a diffuser every night when sleeping Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) This study has incomplete disclosure; interested individuals will be told that there is incomplete disclosure. There will be 2 natural compounds; the compounds are like essential oils and are commercially available. They will be used as intended with diffusers. To prevent any bias, the study team will not tell the participant what compounds are being studied during the time of consent and participation. There will be a debriefing session after the participant is done participating, to tell them about the compounds and to answer any questions. | Other: Natural Compound A (masked essential oil A)<br>* Participants will use Natural Compound A in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).<br>Other: Natural Compound B (masked essential oil B)<br>* Participants will use Natural Compound B in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).<br>|
| Experimental: Group B- Natural Compound B to Natural Compound A<br>Cycle 1 (4 weeks): use diffused Natural Compound B (like an essential oil) in a diffuser every night when sleeping Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period) Cycle 3 (4 weeks): use diffused Natural Compound A (like an essential oil) in a diffuser every night when sleeping Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) This study has incomplete disclosure; interested individuals will be told that there is incomplete disclosure. There will be 2 natural compounds; the compounds are like essential oils and are commercially available. They will be used as intended with diffusers. To prevent any bias, the study team will not tell the participant what compounds are being studied during the time of consent and participation. There will be a debriefing session after the participant is done participating, to tell them about the compounds and to answer any questions. | Other: Natural Compound A (masked essential oil A)<br>* Participants will use Natural Compound A in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).<br>Other: Natural Compound B (masked essential oil B)<br>* Participants will use Natural Compound B in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Heart Rate | Change in resting heart rate measured by wearable devices | Baseline; 18 weeks | 
| Heart Rate Variability | Change in resting heart rate measured by wearable devices | Baseline; 18 weeks | 
| Change in sleep quality measured as duration of sleep stages | Duration of each sleep stage [i.e. light, deep, rapid eye movement (REM), wake stages] overnight. Sleep quality will be measured via a wearable device. Sleep quality will be compared to baseline through the other intervention phases. | Baseline; 18 weeks | 
| Profile of Mood States | Change in mood states, a 65 item scale that allow for the quick assessment of transient, fluctuating feelings and enduring affect states. | Baseline; weeks 3, 7, 11, 15, 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolome | Change in personal metabolic states as measured in microsampling by targeted and untargeted metabolomics-- liquid chromatography mass spectrometry (LC-MS)-- compared to baseline through the other intervention phases. Dry blood samples will be collected by microsampling bi-weekly at a consistent time in the morning. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by LC-MS. | Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19 | 
| Proteome | Comparison of protein changes measured in biospecimens obtained through microsampling against baseline values across various intervention phases. Dry blood samples will be collected by microsampling bi-weekly at a consistent time in the morning. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression. | Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19 | 
| Transcriptome | Change in messenger ribonucleic acid (mRNA)-based expression measured in biospecimens compared to baseline through the other intervention phases. | Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19 | 
| Well-being | Change in well-being measured by Five Well-Being index, a 5-item scale providing a 0 - 25 point composite score, with higher scores indicating greater well-being. | Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19 | 
| Perceived Stress | Change in perceived stress measured by Perceived Stress Scale-10, a 10-item scale providing a 0-40 point composite score, with higher scores indicating greater perceived stress. | Baseline; weeks 3, 7, 11, 15, 19 | 
| Generalized Anxiety | Change in anxiety presence and/or severity measured by Generalized Anxiety Disorder-2, a 2-item scale providing a 0-6 point composite score, with higher scores indicating greater anxiety. | Baseline; weeks 3, 7, 11, 15, 19 | 
| Depression | Change in depression presence and/or severity measured by Patient Health Questionnaire-2, a 2-item scale providing a 0-6 point composite score, with higher scores indicating greater severity | Baseline; weeks 3, 7, 11, 15, 19 | 
| Inflammation Profile | Comparison of inflammatory marker changes measured in biospecimens obtained through microsampling against baseline values across various intervention phases. Dry blood samples will be collected by microsampling bi-weekly at a consistent time in the morning. Based on those samples, inflammatory markers will be quantified by targeted 96 Inflammation panel. | Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19 |