An interventional study of Essential Oil Blend (Botanical Combination Product) and Placebo in Healthy, sponsored by dōTERRA International. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by dōTERRA International · Not applicable, Interventional, and Other
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.
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of a multi-modal essential oil-based product system in healthy adolescents and adults aged 18-45 years. Approximately 20 participants per arm will be enrolled and randomized, with the option for sample size expansion following a planned interim analysis.
Participants will be randomized to receive either the investigational product or matching placebo administered through one of four intervention approaches: aromatic use, topical use, internal use, or combined use of all three modalities. The intervention period will be 30 days.
The aromatic intervention consists of diffusion of the assigned product overnight (approximately 8 hours) using a standardized protocol. The topical intervention consists of application of a diluted preparation to specified skin areas prior to bedtime. The internal intervention consists of oral capsule administration twice daily with meals. Participants assigned to the combined group will use all three modalities concurrently. Placebo preparations will be matched for appearance and administration method.
Study assessments will occur at baseline and at the end of the 30-day intervention period. Biological samples will be collected for evaluation of immune-related biomarkers, including complete blood count (CBC), comprehensive metabolic panel (CMP), salivary immunoglobulin A (IgA), and inflammatory cytokines (interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-α], and interleukin-10 [IL-10]). Epigenetic analyses will also be conducted to evaluate changes in gene expression patterns associated with immune function.
Validated subjective outcome measures, including the PROMIS Global Health instrument and the Immune Status Questionnaire, will be administered to assess perceived immune status and overall well-being. Participants will complete compliance and tolerability reporting throughout the study period.
Safety monitoring will include assessment of adverse events, with particular attention to dermatologic, respiratory, and gastrointestinal symptoms potentially associated with essential oil exposure. The study incorporates an adaptive design with planned interim analysis after initial enrollment targets are reached to guide potential expansion or completion of study arms.
The primary objective is to evaluate changes in immune-related biomarkers following 30 days of product use. Secondary objectives include assessment of subjective immune status, hedonic response, and safety/tolerability of aromatic, topical, internal, and combined administration modalities.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
Participants assigned to this arm will diffuse the investigational essential oil blend overnight (approximately 8 hours) for 30 days according to a standardized protocol.
Other: Essential Oil Blend (Botanical Combination Product)
Participants assigned to this arm will diffuse a placebo preparation overnight (approximately 8 hours) for 30 days using the same protocol as the active aromatic arm.
Other: Placebo
Participants assigned to this arm will apply a diluted preparation of the investigational essential oil blend topically prior to bedtime daily for 30 days.
Other: Essential Oil Blend (Botanical Combination Product)
Participants assigned to this arm will apply a placebo preparation topically prior to bedtime daily for 30 days using the same protocol as the active topical arm.
Other: Placebo
Participants assigned to this arm will ingest capsules containing the investigational essential oil blend twice daily with meals for 30 days.
Other: Essential Oil Blend (Botanical Combination Product)
Participants assigned to this arm will ingest placebo capsules twice daily with meals for 30 days.
Other: Placebo
Participants assigned to this arm will use aromatic diffusion, topical application, and oral capsule administration of the investigational essential oil blend daily for 30 days.
Other: Essential Oil Blend (Botanical Combination Product)
Participants assigned to this arm will use placebo preparations for aromatic diffusion, topical application, and oral capsule administration daily for 30 days.
Other: Placebo
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.
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.
Change in Immune Fitness Single-Item Scale (IFIS) Score
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.
Time frame: Baseline to Week 4
Change in Inflammatory Cytokine Levels
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).
Time frame: Baseline and Day 30
Change in Salivary Immunoglobulin A (IgA)
Change from baseline to Day 30 in salivary immunoglobulin A (IgA) concentration.
Time frame: Baseline and Day 30
Change in Complete Blood Count (CBC) Parameters
Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count.
Time frame: Baseline and Day 30
Change in Immune-Related Gene Expression Markers
Change from baseline to Day 30 in epigenetic markers associated with immune regulation.
Time frame: Baseline and Day 30
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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