Lavender Essential Oil-based Product System for Sleep

NCT ID: NCT06510335

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-08-11

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lavender essential oil-based product system

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

doTERRA Serenity Sleep System

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

dōTERRA International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

doTERRA International

Locations

doTERRA International

Pleasant Grove, Utah, United States

Countries

United States

Other Identifiers

DO-123048-SER

Identifier Type: -

Identifier Source: org_study_id