Efficacy and Safety of Acute Topical and Aromatic Essential Oil-Based Products for Cognitive Support
Purpose
This study will evaluate whether the InTune product system may help support attention, memory, focus, and other thinking skills in healthy adults ages 18-64. Participants will be randomly assigned to receive either the InTune products or placebo products that look and feel the same but do not contain active ingredients. Participants will use the products throughout their participation in the study and complete a series of cognitive tests and questionnaires at the beginning and end of the study. Researchers will compare changes in memory performance, self-reported mental clarity and focus, product experiences, and any side effects between the two groups.
Condition
- Healthy
Eligibility
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Able to read and understand English, willing to attend one study visit at the doTERRA campus in Pleasant Grove, UT
Exclusion Criteria
- Regular use (topical, aromatic, or internal) of rosemary, copaiba, cedarwood, peppermint, wild orange, Spanish sage, lime peel, marjoram, litsea, agarwood, vetiver, hiba wood, elderberry extract, or vanilla essential oil in the past month - Allergy or sensitivity to rosemary, copaiba, cedarwood, peppermint, wild orange, Spanish sage, lime peel, marjoram, litsea, agarwood, vetiver, hiba wood, elderberry extract, or vanilla essential oil - Use of recreational drugs within the past month - Color blindness - Pregnancy, either currently or within the last 3 months - Participation in a clinical trial within the past 30 days - Medical conditions, medications, or allergies that could compromise safety or data integrity, as determined by the medical reviewer or principal investigator
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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 |
|---|---|---|
|
Experimental InTune system |
Aromatic use will entail breathing from a passive nasal aroma stick several times during cognitive testing, as directed by the survey and study staff. The aroma stick will contain 5 drops of InTune essential oil blend on a cotton wick inside a hard plastic casing with a lid. Topical use will entail applying a solid stick to inner arms and chest directly before daily cognitive training. The stick includes a moisturizing base and 25% InTune essential oil blend plus hiba wood oil and elderberry extract. Placebo is the moisturizing base only. |
|
|
Placebo Comparator Placebo |
Aromatic use will entail breathing from a passive nasal aroma stick several times during cognitive testing, as directed by the survey and study staff. The placebo aroma stick will contain 5 drops of benzaldehyde diluted to 1% in fractionated coconut oil on a cotton wick inside a hard plastic casing with a lid. Topical use will entail applying a solid stick to inner arms and chest directly before daily cognitive training. The stick is a moisturizing base (similar to deodorant). |
|
Recruiting Locations
Pleasant Grove, Utah 84020
More Details
- Status
- Recruiting
- Sponsor
- dōTERRA International
Detailed Description
Cognitive performance in adolescents and young to mid-adults directly influences academic success, workplace productivity, decision-making, and daily functioning. Although cognitive decline is typically studied in older populations, attention, working memory, executive function, and mental fatigue are highly relevant in individuals aged 18-64, particularly under conditions of academic, occupational, and digital demands. Neural plasticity remains active throughout this period, making cognitive function potentially modifiable. Despite strong consumer interest in products marketed for focus and mental clarity, well-controlled trials in healthy young and mid-adult populations remain limited. This study aims to address that gap by rigorously evaluating a non-pharmaceutical cognitive support system together with cognitive training in an actively performing population. InTune is a proprietary essential oil blend. Many of the study product components are widely used for cognitive support. Human clinical data are needed on this specific system, justifying an exploratory, adaptive clinical trial.