Efficacy and Safety of Acute Topical and Aromatic Essential Oil-Based Products for Cognitive Support

NCT07623811 | Not Yet Recruiting

• 1 other identifier: DO-126058-ITS
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

neural plasticity; executive function; working memory; Immediate and Delayed Recall; Raven's Matrices; PROMIS Cognitive Scale

Outcome Measures

Primary Outcomes (1)

• Composite Z-Score

  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.

  1 study visit, 90 minutes

Secondary Outcomes (8)

• PROMIS Cognitive Scale

  1 study visit, 90 minutes

• VAS Scales (test difficulty)

  1 study visit, 90 minutes.

• VAS Scale (mental clarity)

  1 study visit, 90 minutes.

• VAS Scale (focus)

  1 study visit, 90 minutes

• VAS Scale (mental energy)

  1 study visit, 90 minutes

Study Arms (2)

InTune system

EXPERIMENTAL

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.

Other: Cognitive Support System

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo

Interventions

Placebo OTHER

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).

Placebo

Cognitive Support System OTHER

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.

InTune system

Eligibility Criteria

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

You may qualify if:

• Able to read and understand English, willing to attend one study visit at the doTERRA campus in Pleasant Grove, UT

You may not qualify if:

• 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

Sponsors & Collaborators

• dōTERRA International: lead

Study Officials

• Nicole Stevens, PhD

  doTERRA International LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Stevens, PhD

CONTACT

8016522822; clinicalresearch@pmhclinics.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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06