Efficacy and Safety of an Essential Oil-Based Product System for Immune Support (OGS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Essential Oil Blend (Botanical Combination Product); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Stevens, PhD; Phone Number: 801-356-5928; Email: nstevens@doterra.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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 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.	Drug: 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.
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.	Drug: 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 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.	Drug: 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.
Experimental: Internal - Active; Participants assigned to this arm will ingest capsules containing the investigational essential oil blend twice daily with meals for 30 days.	Drug: 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 Comparator: Internal - Placebo; Participants assigned to this arm will ingest placebo capsules twice daily with meals for 30 days.	Drug: 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.
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.	Drug: 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 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and Day 30
Change in Salivary Immunoglobulin A (IgA)	Change from baseline to Day 30 in salivary immunoglobulin A (IgA) concentration.	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.	Baseline and Day 30
Change in Immune-Related Gene Expression Markers	Change from baseline to Day 30 in epigenetic markers associated with immune regulation.	Baseline and Day 30
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.	Baseline to Week 4

Collaborators and Investigators

• Sponsor: dōTERRA International
• Investigators: Principal Investigator: Nicole Stevens, PhD, DoTERRA International LLC.

Study record dates

Study Major Dates

• Study Start (Estimated): June 4, 2026
• Primary Completion (Estimated): July 12, 2026
• Study Completion (Estimated): September 17, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Cytokines; Epigenetics; Aromatherapy; Oral administration; Essential oils; Topical administration; Immune biomarkers
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation
• Other Study ID Numbers: DO-126068-OGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No