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

Официальное название

Efficacy and Safety of Acute Topical and Aromatic Essential Oil-Based Products for Cognitive Support. A Double-Blind, Placebo-Controlled, Parallel, Adaptive Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).
• Другое 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

Первичные конечные точки

• Composite Z-Score [Срок оценки: 1 study visit, 90 minutes]

Вторичные конечные точки (8)

• PROMIS Cognitive Scale [Срок оценки: 1 study visit, 90 minutes]
• VAS Scales (test difficulty) [Срок оценки: 1 study visit, 90 minutes.]
• VAS Scale (mental clarity) [Срок оценки: 1 study visit, 90 minutes.]
• VAS Scale (focus) [Срок оценки: 1 study visit, 90 minutes]
• VAS Scale (mental energy) [Срок оценки: 1 study visit, 90 minutes]
• VAS Scale (calmness) [Срок оценки: 1 study visit, 90 minutes]
• Incidence of Adverse Events [Срок оценки: 1 study visit, 90 minutes]
• Product feedback [Срок оценки: 1 study visit, 90 minutes.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07623811 · DO-126058-ITS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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