Beneficial Exposome Study
Beneficial Exposome: Investigating Its Effect on Human Health
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Apr 2024
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
April 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedDecember 4, 2024
November 1, 2024
2 years
October 4, 2023
November 30, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Resting Heart Rate
Change in resting heart rate measured by wearable devices
Baseline; 26 weeks
Heart Rate Variability
Change in resting heart rate measured by wearable devices
Baseline; 26 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; 26 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 2, 6, 10, 14, 18, 22, and 26
Secondary Outcomes (8)
Metabolome
Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Proteome
Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Transcriptome
Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Well-being
Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Perceived Stress
Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
- +3 more secondary outcomes
Study Arms (3)
Group A- Natural Compound A to Natural Compound B to Natural Compound C
EXPERIMENTAL* Cycle 1 (4 weeks): use diffused "Natural Compound A" (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" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.
Group B- Natural Compound B to Natural Compound C to Natural Compound A
EXPERIMENTAL* Cycle 1 (4 weeks): use diffused "Natural Compound B" (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 C" (control) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.
Group C- Natural Compound C to Natural Compound A to Natural Compound B
EXPERIMENTAL* Cycle 1 (4 weeks): use diffused "Natural Compound C" (control) 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" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) * Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping * Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.
Interventions
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).
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).
Participants will use "Natural Compound C" 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).
Eligibility Criteria
You may qualify if:
- years of age and older
- Read, speak, and understand English
- Live in the US territory
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Palo Alto, California, 94304, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Snyder, PhD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Genetics & Genetics Department Chair
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 23, 2023
Study Start
April 16, 2024
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
December 4, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
No current plan to share data.