Lavender Essential Oil-based Product System for Sleep
NCT Number: NCT06510335
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: OTHER: Lavender essential oil-based product system
Sponsor: dōTERRA International
Sex: ALL
Age: ADULT
Enrollment: 46
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2023-06-01
Completion Date: 2023-08-11
Locations: doTERRA International, Pleasant Grove, Utah, 84062, United States

Summary:
The goal of this clinical trial is to learn whether lavender essential oil-based product system can affect gene expression, serum protein markers, and sleep quality in healthy volunteers. The main questions this study aims to answer are:

* Does the lavender essential oil-based product system affect gene expression and protein markers as measured in blood?
* Does the lavender essential oil-based product system affect subjective quality of life and sleep assessments?
* Is daily use of the product system safe, as measured by laboratory tests and adverse events?

The lavender essential oil-based product system contains three components: an essential oil blend, a topical stick, and a dietary supplement.

Participants will:

* Receive a fitness tracker to monitor their sleep and physical activity.
* Use the lavender essential oil-based product system for six weeks total according to this schedule:
* 1 week: Essential oil blend
* 1 week: Essential oil blend + topical stick
* 4 weeks: Essential oil blend + topical stick + dietary supplement
* Attend two study visits in which they provide blood and urine samples, and complete subjective sleep and quality of life assessments
* Complete weekly subjective sleep assessments from home

Primary Outcome Measures: Gene expression, Gene expression analysis refers to a genome-wide quantification of methylation. This represents approximately 900,000 gene locations. The main feature performed is a differential methylation analysis to determine what has significantly changed from one time point to another., 6 weeks|Interleukin 6 (pg/mL), Serum marker for inflammation, 6 weeks|Cortisol (ug/mL), Serum marker for stress response, 6 weeks|Uric acid (mg/dL), Serum marker for inflammation and signal of developing various disease processes, 6 weeks|C-reactive protein (mg/L), Serum marker for inflammation, 6 weeks|Minutes awake, Mean nightly minutes awake determined by fitness tracker, 6 weeks|Minutes asleep, Mean nightly minutes asleep determined by fitness tracker, 6 weeks|Number of awakenings, Mean nightly number of awakenings determined by fitness tracker, 6 weeks|Rapid Eye Movement (REM) sleep (minutes), Mean nightly minutes of REM sleep determined by fitness tracker, 6 weeks|Light sleep (minutes), Mean nightly minutes of light sleep determined by fitness tracker, 6 weeks|Deep sleep (minutes), Mean nightly minutes of deep sleep determined by fitness tracker, 6 weeks
Secondary Outcome Measures: Albumin (g/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Blood urea nitrogen (BUN) (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Creatinine (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Alkaline phosphatase (U/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Alanine transaminase (ALT) (U/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Aspartate aminotransferase (AST) (U/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Calcium (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Carbon Dioxide (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Chloride (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Potassium (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Sodium (mmol/L), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Total bilirubin (mg/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Total protein (g/dL), Item in comprehensive metabolic panel for safety assessment, 6 weeks|Safety/tolerability, This study will monitor the occurrence and frequency of adverse events and safety through participant report and blood analyses., 6 weeks|Leeds Sleep Evaluation Questionnaire (LSEQ), Validated, self-reported scale for the measurement of sleep quality. The LSEQ is a 10-item scale. Each item is scored 0 to 100. Higher scores indicate better sleep quality., 6 weeks|Short Form-20 (SF-20) scale, Validated, self-reported scale for the assessment of subjective quality of life. The SF-20 is a 20-item scale. Each item is scored 0-100. Higher scores indicate better subjective quality of life., 6 weeks|Functional Outcomes of Sleep Questionnaire (FOSQ), Validated, self-reported scale for the measurement of sleep quality. The FOSQ is a 10-item scale. Higher scores indicate better sleep-related functional outcomes., 6 weeks