NCT Number: NCT07623811
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.
Trial opening soon.
Get Notified18 year–64 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 study visit, 90 minutes
Number and severity of participant-reported adverse events occurring during the study visit.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
dōTERRA International
Industry
Efficacy and Safety of Acute Topical and Aromatic Essential Oil-Based Products for Cognitive Support. A Double-Blind, Placebo-Controlled, Parallel, Adaptive Trial.
Acronym: ITS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07737496
Healthy
Changsha, Hunan, China
View Trial DetailsNCT07727785
Healthy
Biberach, Germany
View Trial DetailsNCT07725809
Body Weight, Healthy
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT07678567
Alcohol Use Disorder, Alcohol-Induced Disorders
Louisville, Kentucky, United States
View Trial Details