Efficacy and Safety of an Essential Oil-Based Product System for Immune Support
Purpose
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.
Condition
- Healthy
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized in a parallel-group design to receive either investigational product or matching placebo administered via aromatic, topical, internal, or combined modalities for 30 days. Participants will remain in their assigned group for the duration of the study. Randomization will be stratified by age group and gender. The study is double-blind, and all intervention groups will be conducted concurrently.
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- This study is double-blind. Participants, investigators, study staff, and outcome assessors will be blinded to treatment assignment. Active and placebo products will be matched in appearance, packaging, labeling, and method of administration. Randomization codes will be generated and maintained by an independent party and will not be accessible to blinded study personnel. Unblinding will occur only after completion of the study or at the time of a pre-specified interim analysis conducted by a designated statistician not involved in participant interaction or outcome assessment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental Aromatic - Active |
Participants assigned to this arm will diffuse the investigational essential oil blend overnight (approximately 8 hours) for 30 days according to a standardized protocol. |
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Placebo Comparator Aromatic - Placebo |
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. |
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|
Experimental Topical - Active |
Participants assigned to this arm will apply a diluted preparation of the investigational essential oil blend topically prior to bedtime daily for 30 days. |
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|
Placebo Comparator Topical - Placebo |
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. |
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|
Experimental Internal - Active |
Participants assigned to this arm will ingest capsules containing the investigational essential oil blend twice daily with meals for 30 days. |
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Placebo Comparator Internal - Placebo |
Participants assigned to this arm will ingest placebo capsules twice daily with meals for 30 days. |
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|
Experimental Combined - Active |
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. |
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|
Placebo Comparator Combined - Placebo |
Participants assigned to this arm will use placebo preparations for aromatic diffusion, topical application, and oral capsule administration daily for 30 days. |
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Recruiting Locations
Pleasant Grove, Utah 84062
More Details
- Status
- Recruiting
- Sponsor
- dōTERRA International
Detailed Description
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.