Clinical trial NCT06510335: Lavender Essential Oil-based Product System for Sleep
Official title: Evaluation of a Lavender-based Natural Product System for Sleep Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Lavender essential oil
Sleep quality
Gene expression
Lead sponsor: dōTERRA International
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Males and females, 35-50 years old
* Non-smokers
* Local to Pleasant Grove, Utah, and/or willing to come to clinical research center for study visits
* Willing and able to apply study products internally, topically and aromatically for about 6 weeks
* Willing to track use of study product on paper forms, via survey, or other means
* Willing to washout from all over-the-counter sleep aids, internally-consumed essential oils, alcohol, and lavender-based products for approximately 7 weeks
* Taking \<100 mg caffeine daily, and willing to avoid consumption of caffeine after 3pm
* Not working night shift or swing shift
* Not consistently traveling to other time zones (or willing to arrange schedule to avoid during study)
* No known medical condition or sensitivity which would make the application of these study products unsafe
* Own a smart device that can download and run the accelerometer application
* Willing and able to keep the same sleeping arrangements as much as possible throughout the study
* Willing to receive and respond to regular texts, emails, and/or phone calls from study staff
* No pregnancy within the last 60 days or currently breastfeeding (females)
* Not currently or previously participating in any other clinical trial within the last 30 calendar days
* Signed informed consent, HIPAA Authorization, and Confidentiality Agreement
* No major medical conditions (especially cardiac, lung, metabolic, cancer, or sleep) under the active care of a doctor
* No prescription medications that may interfere with sleep (e.g. attention deficit hyperactivity disorder stimulants, antihistamines, psychiatric drugs, sleep medications, narcotics, etc.)
* No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical reviewer, put the participant at risk or affect study results, procedures, or outcomes (e.g. obstructive sleep apnea, morbid obesity, cardiometabolic disease, cancer, lung-related conditions)
* Willing and able (in the opinion of the investigator) to comply with all study requirements and procedures

Exclusion Criteria:

* Failure to meet any of the above inclusion criteria

Primary outcomes:
measure: Gene expression
timeFrame: 6 weeks
measure: Interleukin 6 (pg/mL)
timeFrame: 6 weeks
measure: Cortisol (ug/mL)
timeFrame: 6 weeks
measure: Uric acid (mg/dL)
timeFrame: 6 weeks
measure: C-reactive protein (mg/L)
timeFrame: 6 weeks
measure: Minutes awake
timeFrame: 6 weeks
measure: Minutes asleep
timeFrame: 6 weeks
measure: Number of awakenings
timeFrame: 6 weeks
measure: Rapid Eye Movement (REM) sleep (minutes)
timeFrame: 6 weeks
measure: Light sleep (minutes)
timeFrame: 6 weeks
measure: Deep sleep (minutes)
timeFrame: 6 weeks
Secondary outcomes:
measure: Albumin (g/dL)
timeFrame: 6 weeks
measure: Blood urea nitrogen (BUN) (mg/dL)
timeFrame: 6 weeks
measure: Creatinine (mg/dL)
timeFrame: 6 weeks
measure: Alkaline phosphatase (U/L)
timeFrame: 6 weeks
measure: Alanine transaminase (ALT) (U/L)
timeFrame: 6 weeks
measure: Aspartate aminotransferase (AST) (U/L)
timeFrame: 6 weeks
measure: Calcium (mg/dL)
timeFrame: 6 weeks
measure: Carbon Dioxide (mmol/L)
timeFrame: 6 weeks
measure: Chloride (mmol/L)
timeFrame: 6 weeks
measure: Potassium (mmol/L)
timeFrame: 6 weeks
measure: Sodium (mmol/L)
timeFrame: 6 weeks
measure: Total bilirubin (mg/dL)
timeFrame: 6 weeks
measure: Total protein (g/dL)
timeFrame: 6 weeks
measure: Safety/tolerability
timeFrame: 6 weeks
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: 6 weeks
measure: Short Form-20 (SF-20) scale
timeFrame: 6 weeks
measure: Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Pleasant Grove
country: United States
facility: doTERRA International
state: Utah
Study officials:
affiliation: doTERRA International
name: Nicole Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: