Clinical trial NCT06093464: Beneficial Exposome Study
Official title: Beneficial Exposome: Investigating Its Effect on Human Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will do the intervention but at different times and in different orders.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resting Heart Rate
timeFrame: Baseline; 26 weeks
measure: Heart Rate Variability
timeFrame: Baseline; 26 weeks
measure: Change in sleep quality measured as duration of sleep stages
timeFrame: Baseline; 26 weeks
measure: Profile of Mood States
timeFrame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Secondary outcomes:
measure: Metabolome
timeFrame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
measure: Proteome
timeFrame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
measure: Transcriptome
timeFrame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
measure: Well-being
timeFrame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
measure: Perceived Stress
timeFrame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
measure: Generalized Anxiety
timeFrame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
measure: Depression
timeFrame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
measure: Inflammation Profile
timeFrame: Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michael Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
References: