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

NCT07482644 | Not Yet Recruiting

• 1 other identifier: DO-126068-OGS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Immune System Function; Inflammation

Keywords

Essential oils; Aromatherapy; Immune biomarkers; Topical administration; Oral administration; Cytokines; Inflammation; Epigenetics

Outcome Measures

Primary Outcomes (5)

• 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 0-10 scale, from baseline to Week 4. Weekly IFIS assessments will be used to estimate treatment effects over time.

  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).

  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

Study Arms (8)

Aromatic - Active

EXPERIMENTAL

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)

Aromatic - Placebo

PLACEBO COMPARATOR

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

Topical - Active

EXPERIMENTAL

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)

Topical - Placebo

PLACEBO COMPARATOR

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

Internal - Active

EXPERIMENTAL

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)

Internal - Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will ingest placebo capsules twice daily with meals for 30 days.

Drug: Placebo

Combined - Active

EXPERIMENTAL

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)

Combined - Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will use placebo preparations for aromatic diffusion, topical application, and oral capsule administration daily for 30 days.

Drug: Placebo

Interventions

Essential Oil Blend (Botanical Combination Product) DRUG

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.

Aromatic - Active; Combined - Active; Internal - Active; Topical - Active

Placebo DRUG

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.

Aromatic - Placebo; Combined - Placebo; Internal - Placebo; Topical - Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• dōTERRA International: lead

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole Stevens, PhD

  DoTERRA International LLC.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Stevens, PhD

CONTACT

801-356-5928; nstevens@doterra.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share