Healthy
Conditions
Keywords
neural plasticity, executive function, working memory, Immediate and Delayed Recall, Raven's Matrices, PROMIS Cognitive Scale
Brief summary
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.
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.
Interventions
OTHERPlacebo
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).
OTHERCognitive Support System
InTune is a product system including an essential oil blend and active botanicals delivered in a liquid form for aromatic application and a solid stick for topical application. 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.
Sponsors
dōTERRA International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Z-Score | 1 study visit, 90 minutes | Within- and between-treatment changes to composite z-score comprised of Stroop, Backward Digit Span, Immediate and Delayed Recall, and Raven's Matrices tests from baseline to completion will be the primary outcome. A higher composite z-score indicates better overall cognitive performance (e.g., improved attention, memory, processing speed, and reasoning). Lower composite z-scores indicate poorer cognitive performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Cognitive Scale | 1 study visit, 90 minutes | The Patient-Reported Outcome Measurement Information System (PROMIS) Cognitive subjective survey assesses patient-perceived cognitive deficits. Aspects include mental acuity, concentration, verbal fluency, verbal and nonverbal memory, and perceived changes in cognitive functions. Participants report their answers on a scale of 1 to 5. A higher score indicates a more positive perception of cognition. A lower score indicates a poorer perception of one's cognitive abilities. |
| VAS Scales (test difficulty) | 1 study visit, 90 minutes. | A Visual Analog Scale (VAS) is a measurement tool with a scale of 0 to 100. For test difficulty, a score of 0 indicates a lower perception of difficulty, while a high score of 100 indicates a higher perception of difficulty. |
| VAS Scale (mental clarity) | 1 study visit, 90 minutes. | The Visual Analog Scale (VAS) for mental clarity assesses perception of mental clarity on a scale of 0 to 100. Higher scores indicate a perception of greater mental clarity. |
| VAS Scale (focus) | 1 study visit, 90 minutes | The Visual Analog Scale (VAS) for focus assesses perception of one's ability to focus, on a scale of 0 to 100. Higher scores indicate a perception of greater ability to focus. |
| VAS Scale (mental energy) | 1 study visit, 90 minutes | The Visual Analog Scale (VAS) for mental energy assesses perception of mental energy on a scale of 0 to 100. Higher scores indicate a perception of greater mental energy. |
| VAS Scale (calmness) | 1 study visit, 90 minutes | The Visual Analog Scale (VAS) for calmness assesses perception of calmness on a scale of 0 to 100. Higher scores indicate a perception of greater calmness. |
| Incidence of Adverse Events | 1 study visit, 90 minutes | Number and severity of participant-reported adverse events occurring during the study visit. |
| Product feedback | 1 study visit, 90 minutes. | Feedback on the aroma of the topical product and aromatic product, and sensations felt during the application and use of the study products. |
Countries
United States
Contacts
CONTACTNicole Stevens, PhD
PRINCIPAL_INVESTIGATORNicole Stevens, PhD
doTERRA International LLC
Outcome results
None listed