Active, not recruiting
Not applicable
Efficacy and Safety of an Essential Oil-Based Product System for Immune Support
Condition(s) studied
Healthy
Investigational drug(s) / intervention(s)
Essential Oil Blend (Botanical Combination Product)Placebo
Essential Oil Blend (Botanical Combination Product): A botanical essential oil blend administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days. Aromatic administration consists of diffusion of the assigned product overnight (approximately 8 hours) using a standardized protocol. Topical administration consists of application of a diluted preparation to specified skin areas prior to bedtime. Internal administration consists of oral capsule ingestion twice daily with meals. Dosage and administration procedures are standardized across study arms.
Placebo: Matching placebo preparations administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days using the same procedures and schedule as the active intervention.
Study summary
This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety and efficacy of an essential oil-based product system for immune support in healthy adolescents and adults aged 18-45 years. Participants will be randomized to receive aromatic, topical, internal, or combined use of the investigational product or matching placebo for 30 days.
The aromatic intervention consists of overnight diffusion, the topical intervention consists of diluted application to specified areas prior to bedtime, and the internal intervention consists of oral capsule administration twice daily. Study visits will occur at baseline and at the end of the 30-day intervention period.
Primary outcomes include changes in immune-related biomarkers, including complete blood count, comprehensive metabolic panel, salivary immunoglobulin A (IgA), and inflammatory cytokines (IL-6, TNF-α, IL-10). Epigenetic markers will also be evaluated. Secondary outcomes include validated subjective assessments of immune status and overall well-being, as well as evaluation of safety and tolerability.
The study includes an adaptive design with interim analysis to assess enrollment and study continuation parameters.
Eligibility
Inclusion Criteria:
* Healthy male or female participants aged 18 to 45 years
* Able to read, write, and understand English
* Willing and able to attend study visits at the study site
* Willing to comply with study procedures, including daily use of assigned study product for 30 days
* Willing to refrain from use of essential oils (topical, aromatic, or internal) outside of the study during the study period
* If previously using essential oils regularly (defined as more than 3 times per week for 2 or more weeks in the past month), must complete a washout period of at least 1 month prior to enrollment
Exclusion Criteria:
* Known asthma, chronic obstructive pulmonary disease (COPD), chronic lung disease, heart disease, or other medical condition that would make inhalation of essential oils unsafe, as determined by the investigator
* Known allergy or hypersensitivity to essential oils or components of the placebo preparation
* Current use of tobacco products, including smoking, vaping, or chewing tobacco
* Use of recreational drugs
* Pregnant or breastfeeding, or pregnancy within the past 3 months
* Current regular use of essential oils (defined as more than 3 times per week for 2 or more weeks within the past month) without completion of a 1-month washout period
* Initiation of new botanical supplements during the study period
* Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with safe participation or study compliance
Primary outcome measure(s)
- Change in Immune Fitness Single-Item Scale (IFIS) Score — Baseline to Week 4
Within- and between-group change in perceived immune fitness as measured by the Immune Fitness Single-Item Scale (IFIS), a single-item scale ranging from 0 (very poor) to 10 (excellent), from baseline to Week 4. Weekly IFIS assessments will be used to estimate treatment effects over time. A higher score indicates a perception of greater/stronger immune fitness.
- Change in Inflammatory Cytokine Levels — Baseline and Day 30
Change from baseline to Day 30 in serum concentrations of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10).
- Change in Salivary Immunoglobulin A (IgA) — Baseline and Day 30
Change from baseline to Day 30 in salivary immunoglobulin A (IgA) concentration.
- Change in Complete Blood Count (CBC) Parameters — Baseline and Day 30
Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count.
- Change in Immune-Related Gene Expression Markers — Baseline and Day 30
Change from baseline to Day 30 in epigenetic markers associated with immune regulation.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| dōTERRA International |
Pleasant Grove |
Utah |
|
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