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
This single-blind study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of sleep system products for 6 weeks. Quality of life and sleep quality will be assessed using subjective surveys and questionnaires. Safety markers (liver and kidney function, hematology, urinalysis, and adverse events) will be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
46
Participants used the study products in a sequential, additive manner approximately 30-60 minutes before bedtime each night for 6 weeks. Usage consists of the following: * 20 drops of essential oil blend in approximately 250 mL of water in a diffuser, which operated for 8 hours at nighttime. * 3 x 6" swipes of the topical stick on the upper chest area, and 2 x 3" swipes on the inside of each wrist for topical application. * 2 capsules of the dietary supplement. Participants used the essential oil blend alone for 1 week, then added the topical stick for another 1 week. Finally, participants used the essential oil blend, the topical stick, and the dietary supplement for four weeks.
doTERRA International
Pleasant Grove, Utah, United States
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.
Time frame: 6 weeks
Interleukin 6 (pg/mL)
Serum marker for inflammation
Time frame: 6 weeks
Cortisol (ug/mL)
Serum marker for stress response
Time frame: 6 weeks
Uric acid (mg/dL)
Serum marker for inflammation and signal of developing various disease processes
Time frame: 6 weeks
C-reactive protein (mg/L)
Serum marker for inflammation
Time frame: 6 weeks
Minutes awake
Mean nightly minutes awake determined by fitness tracker
Time frame: 6 weeks
Minutes asleep
Mean nightly minutes asleep determined by fitness tracker
Time frame: 6 weeks
Number of awakenings
Mean nightly number of awakenings determined by fitness tracker
Time frame: 6 weeks
Rapid Eye Movement (REM) sleep (minutes)
Mean nightly minutes of REM sleep determined by fitness tracker
Time frame: 6 weeks
Light sleep (minutes)
Mean nightly minutes of light sleep determined by fitness tracker
Time frame: 6 weeks
Deep sleep (minutes)
Mean nightly minutes of deep sleep determined by fitness tracker
Time frame: 6 weeks
Albumin (g/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Blood urea nitrogen (BUN) (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Creatinine (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Alkaline phosphatase (U/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Alanine transaminase (ALT) (U/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Aspartate aminotransferase (AST) (U/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Calcium (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Carbon Dioxide (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Chloride (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Potassium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 weeks
Sodium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Total bilirubin (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Total protein (g/dL)
Item in comprehensive metabolic panel for safety assessment
Time frame: 6 weeks
Safety/tolerability
This study will monitor the occurrence and frequency of adverse events and safety through participant report and blood analyses.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks