Lavender Essential Oil-based Product System for Sleep

Evaluation of a Lavender-based Natural Product System for Sleep Support

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Lavender essential oil-based product system

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • dōTERRA International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lavender essential oil-based product system; Participants used the system in a sequential additive series. They used only the oil blend aromatically for 1 week, then the aromatic blend plus a topical stick application for 1 week, and then, for 4 weeks, the aromatic blend, the topical stick, and took 2 capsules of the dietary supplement nightly.

Other: Lavender essential oil-based product system; 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.; Other Names: doTERRA Serenity Sleep System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin 6 (pg/mL)	Serum marker for inflammation	6 weeks
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
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
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
Rapid Eye Movement (REM) sleep (minutes)	Mean nightly minutes of REM sleep determined by fitness tracker	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: dōTERRA International
• Investigators: Principal Investigator: Nicole Stevens, PhD, dōTERRA International

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Sleep quality; Gene expression; Lavender essential oil
• Other Study ID Numbers: DO-123048-SER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No