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NCT Number: NCT06093464

Beneficial Exposome Study

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Ji Hyun Kim, MS

CONTACT

[email protected]

650-441-6216

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Resting Heart Rate

    Time frame: Baseline; 26 weeks

    Change in resting heart rate measured by wearable devices

  2. Heart Rate Variability

    Time frame: Baseline; 26 weeks

    Change in resting heart rate measured by wearable devices

  3. 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.

  4. 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.

Secondary outcomes

  1. Metabolome

    Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

    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.

  2. Proteome

    Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

    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.

  3. Transcriptome

    Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

    Change in messenger ribonucleic acid (mRNA)-based expression measured in biospecimens compared to baseline through the other intervention phases.

  4. Well-being

    Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

    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.

  5. Perceived Stress

    Time frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26

    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.

  6. Generalized Anxiety

    Time frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26

    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.

  7. Depression

    Time frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26

    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

  8. Inflammation Profile

    Time frame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Zhang, PhD

CONTACT

[email protected]

Ji Hyun Kim, MS

CONTACT

[email protected]

(650) 441-6216

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Beneficial Exposome: Investigating Its Effect on Human Health

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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