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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Cognitive 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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