Beneficial Exposome Study

Healthy Clinical Trial

Official title:

Beneficial Exposome: Investigating Its Effect on Human Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06093464
• Other study ID #: 71135
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: Ji Hyun Kim, MS
• Phone: (650) 681-9690
• Email: jikimji[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Heart Rate	Change in resting heart rate measured by wearable devices	Baseline; 18 weeks
Primary	Heart Rate Variability	Change in resting heart rate measured by wearable devices	Baseline; 18 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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