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

Part of paid clinical trials in Pleasant Grove, Utah.

Sponsor
dōTERRA International
Study ID
NCT07482644
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 10, 2026
Status verified
Jun 2026
Primary completion
Jul 12, 2026
Completion
Sep 17, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: Internal - Active
    Participants assigned to this arm will ingest capsules containing the investigational essential oil blend twice daily with meals for 30 days.
  • Placebo Comparator: Internal - Placebo
    Participants assigned to this arm will ingest placebo capsules twice daily with meals for 30 days.
  • 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.
  • 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.

Primary Outcome Measure

Change in Immune Fitness Single-Item Scale (IFIS) Score [ Time Frame: Baseline to Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
dōTERRA InternationalPleasant GroveUtah84062
Clinical Research Team
[email protected]

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