Lavender Essential Oil-based Product System for Sleep

NCT06510335 | Completed

• 1 other identifier: DO-123048-SER
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Lavender essential oil; Sleep quality; Gene expression

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (17)

• Albumin (g/dL)

  6 weeks

• Blood urea nitrogen (BUN) (mg/dL)

  6 weeks

• Creatinine (mg/dL)

  6 weeks

• Alkaline phosphatase (U/L)

  6 weeks

• Alanine transaminase (ALT) (U/L)

  6 weeks

Study Arms (1)

Lavender essential oil-based product system

EXPERIMENTAL

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

Interventions

Lavender essential oil-based product system OTHER

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.

Also known as: doTERRA Serenity Sleep System

Lavender essential oil-based product system

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• dōTERRA International: lead

Study Sites (1)

doTERRA International

Pleasant Grove, Utah, 84062, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Nicole Stevens, PhD

  doTERRA International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study includes a single arm. Participants did not know the market name of the products they used. Products were packaged in plain bottles with the instruction label affixed.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: June 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 11, 2023
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

US (1)