Beneficial Exposome Study

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06093464

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Natural Compound A (masked essential oil A) Other: Natural Compound B (masked essential oil B)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

All participants will do the intervention but at different times and in different orders.All participants will do the intervention but at different times and in different orders.

Masking:

Single (Participant)

Masking Description:

This study involves incomplete disclosure and interested individuals will be told that there is incomplete disclosure. There will be 2 natural compounds being used in the study. The natural compounds are similar to essential oils and are commercially available. They will be used as intended with diffusers. To prevent any bias or placebo effects, the study team will not tell the participant what compounds are being studied during the time of consent and participation. The study team will hold a debriefing session after the participant is done participating, to tell them about the compounds and to answer any questions.

Primary Purpose:

Other

Official Title:

Beneficial Exposome: Investigating Its Effect on Human Health

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A- Natural Compound A to Natural Compound B 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) 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). Other: Natural Compound B (masked essential oil B) 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).
Experimental: Group B- Natural Compound B to Natural Compound A 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) 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). Other: Natural Compound B (masked essential oil B) 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).

Arm

Intervention/Treatment

Experimental: Group A- Natural Compound A to Natural Compound B

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)

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).

Other: Natural Compound B (masked essential oil B)

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).

Experimental: Group B- Natural Compound B to Natural Compound A

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)

Other: Natural Compound B (masked essential oil B)

Outcome Measures

Primary Outcome Measures

Resting Heart Rate [Baseline; 18 weeks]
Change in resting heart rate measured by wearable devices
Heart Rate Variability [Baseline; 18 weeks]
Change in resting heart rate measured by wearable devices
Change in sleep quality measured as duration of sleep stages [Baseline; 18 weeks]
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.
Profile of Mood States [Baseline; weeks 3, 7, 11, 15, 19]
Change in mood states, a 65 item scale that allow for the quick assessment of transient, fluctuating feelings and enduring affect states.

Secondary Outcome Measures

Metabolome [Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19]
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.
Proteome [Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19]
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.
Transcriptome [Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19]
Change in messenger ribonucleic acid (mRNA)-based expression measured in biospecimens compared to baseline through the other intervention phases.
Well-being [Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19]
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.
Perceived Stress [Baseline; weeks 3, 7, 11, 15, 19]
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.
Generalized Anxiety [Baseline; weeks 3, 7, 11, 15, 19]
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.
Depression [Baseline; weeks 3, 7, 11, 15, 19]
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
Inflammation Profile [Baseline; weeks 3, 5, 7, 9, 11, 13, 15, 17, 19]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Michael Snyder, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Snyder, Professor of Genetics & Genetics Department Chair, Stanford University

ClinicalTrials.gov Identifier:

NCT06093464

Other Study ID Numbers:

71135

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Corticosterone

Study Results

No Results Posted as of Oct 23, 2023