HealthyNCT06093464
Beneficial Exposome Study
A study testing Natural Compound A (Hinoki essential oil) and Natural Compound B (Lemon essential oil) in people with Healthy, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Natural Compound A (Hinoki essential oil) and Natural Compound B (Lemon essential oil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Read, speak, and understand English
- Live in the US territory
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Allison Zhang, PhD contact
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Ji Hyun Kim, MS, 650-441-6216, jikimji@stanford.edu
About this study
Official title: Beneficial Exposome: Investigating Its Effect on Human Health
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Natural Compound A (Hinoki essential oil), Natural Compound B (Lemon essential oil), Natural Compound C (Control/Water)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Compound A (Hinoki essential oil)Other
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).
Natural Compound B (Lemon essential oil)Other
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).
Natural Compound C (Control/Water)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Natural Compound A (Hinoki essential oil); Other: Natural Compound B (Lemon essential oil); Other: Natural Compound C (Control/Water) |
| 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. Receives: Other: Natural Compound A (Hinoki essential oil); Other: Natural Compound B (Lemon essential oil); Other: Natural Compound C (Control/Water) |
| 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. Receives: Other: Natural Compound A (Hinoki essential oil); Other: Natural Compound B (Lemon essential oil); Other: Natural Compound C (Control/Water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Heart Rate
Change in resting heart rate measured by wearable devices
Measured: Baseline; 26 weeks
Heart Rate Variability
Change in resting heart rate measured by wearable devices
Measured: 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.
Measured: 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.
Measured: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Secondary outcomes (8)
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.
Measured: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
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.
Measured: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Transcriptome
Change in messenger ribonucleic acid (mRNA)-based expression measured in biospecimens compared to baseline through the other intervention phases.
Measured: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
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.
Measured: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
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.
Measured: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
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.
Measured: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
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
Measured: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
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.
Measured: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start16 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will do the intervention but at different times and in different orders.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Snyder, Stanford University
- Investigators
- Michael Snyder, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093464
- Sponsor's protocol ID
- 71135
- Status last verified
- Nov 2024
- First submitted
- 4 Oct 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Exposome: Investigating Its Effect on Human Health
- ClinicalTrials.gov ID
- NCT06093464
- Acronym / sponsor ID
- 71135
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants will do the intervention but at different times and in different orders.
| Arm | Type | Receives |
|---|---|---|
| Group A- Natural Compound A to Natural Compound B to Natural Compound C | Experimental | Other: Natural Compound A (Hinoki essential oil), Other: Natural Compound B (Lemon essential oil), Other: Natural Compound C (Control/Water)* 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 | Other: Natural Compound A (Hinoki essential oil), Other: Natural Compound B (Lemon essential oil), Other: Natural Compound C (Control/Water)* 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 | Other: Natural Compound A (Hinoki essential oil), Other: Natural Compound B (Lemon essential oil), Other: Natural Compound C (Control/Water)* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Read, speak, and understand English
- Live in the US territory
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Compound A (Hinoki essential oil)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 | Group A- Natural Compound A to Natural Compound B to Natural Compound C, Group B- Natural Compound B to Natural Compound C to Natural Compound A, Group C- Natural Compound C to Natural Compound A to Natural Compound B |
| Natural Compound B (Lemon essential oil)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). | Other | Group A- Natural Compound A to Natural Compound B to Natural Compound C, Group B- Natural Compound B to Natural Compound C to Natural Compound A, Group C- Natural Compound C to Natural Compound A to Natural Compound B |
| Natural Compound C (Control/Water)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). | Other | Group A- Natural Compound A to Natural Compound B to Natural Compound C, Group B- Natural Compound B to Natural Compound C to Natural Compound A, Group C- Natural Compound C to Natural Compound A to Natural Compound B |
Primary outcome
Resting Heart Rate
Time frame: Baseline; 26 weeks
Change in resting heart rate measured by wearable devices
Heart Rate Variability
Time frame: Baseline; 26 weeks
Change in resting heart rate measured by wearable devices
Change in sleep quality measured as duration of sleep stages
Time frame: Baseline; 26 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
Time frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Change in mood states, a 65 item scale that allow for the quick assessment of transient, fluctuating feelings and enduring affect states.
8 secondary outcomes
Metabolome
Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Proteome
Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Transcriptome
Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Well-being
Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Perceived Stress
Time frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Generalized Anxiety
Time frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Depression
Time frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Inflammation Profile
Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No. No current plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Zhang, PhD contact
Michael Snyder, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Compound A (Hinoki essential oil) and Natural Compound B (Lemon essential oil) in people with Healthy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ji Hyun Kim, MS ((650) 441-6216, jikimji@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Heart Rate (time frame: Baseline; 26 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.