HealthyNCT06510335
Lavender Essential Oil-based Product System for Sleep
A study testing Lavender essential oil-based product system in people with Healthy, run by dōTERRA International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lavender essential oil-based product system
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- Failure to meet any of the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
Read the 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
- Being tested
- Lavender essential oil-based product system
- Keywords
- Lavender essential oil, Sleep quality, Gene expression
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender essential oil-based product systemOther
Also called doTERRA Serenity Sleep 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lavender essential oil-based product system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Interleukin 6 (pg/mL)
Serum marker for inflammation
Measured: 6 weeks
Cortisol (ug/mL)
Serum marker for stress response
Measured: 6 weeks
Uric acid (mg/dL)
Serum marker for inflammation and signal of developing various disease processes
Measured: 6 weeks
C-reactive protein (mg/L)
Serum marker for inflammation
Measured: 6 weeks
Minutes awake
Mean nightly minutes awake determined by fitness tracker
Measured: 6 weeks
Minutes asleep
Mean nightly minutes asleep determined by fitness tracker
Measured: 6 weeks
Number of awakenings
Mean nightly number of awakenings determined by fitness tracker
Measured: 6 weeks
Rapid Eye Movement (REM) sleep (minutes)
Mean nightly minutes of REM sleep determined by fitness tracker
Measured: 6 weeks
Light sleep (minutes)
Mean nightly minutes of light sleep determined by fitness tracker
Measured: 6 weeks
Deep sleep (minutes)
Mean nightly minutes of deep sleep determined by fitness tracker
Measured: 6 weeks
Secondary outcomes (17)
Albumin (g/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Blood urea nitrogen (BUN) (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Creatinine (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Alkaline phosphatase (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Alanine transaminase (ALT) (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Aspartate aminotransferase (AST) (U/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Calcium (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Carbon Dioxide (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Chloride (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Potassium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Sodium (mmol/L)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Total bilirubin (mg/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Total protein (g/dL)
Item in comprehensive metabolic panel for safety assessment
Measured: 6 weeks
Safety/tolerability
This study will monitor the occurrence and frequency of adverse events and safety through participant report and blood analyses.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Jun 2023
- Primary completion1 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- dōTERRA International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Stevens, PhD, Principal investigator, doTERRA International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510335
- Sponsor's protocol ID
- DO-123048-SER
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Lavender-based Natural Product System for Sleep Support
- ClinicalTrials.gov ID
- NCT06510335
- Acronym / sponsor ID
- DO-123048-SER
- Conditions
- Healthy
- Keywords
- Lavender essential oil, Sleep quality, Gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- dōTERRA InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lavender essential oil-based product system | Experimental | Other: Lavender essential oil-based product systemParticipants 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. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet any of the above inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender essential oil-based product systemAlso: doTERRA Serenity Sleep SystemParticipants 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 | Lavender essential oil-based product system |
Primary outcome
Gene expression
Time frame: 6 weeks
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.
Interleukin 6 (pg/mL)
Time frame: 6 weeks
Serum marker for inflammation
Cortisol (ug/mL)
Time frame: 6 weeks
Serum marker for stress response
Uric acid (mg/dL)
Time frame: 6 weeks
Serum marker for inflammation and signal of developing various disease processes
C-reactive protein (mg/L)
Time frame: 6 weeks
Serum marker for inflammation
Minutes awake
Time frame: 6 weeks
Mean nightly minutes awake determined by fitness tracker
Minutes asleep
Time frame: 6 weeks
Mean nightly minutes asleep determined by fitness tracker
Number of awakenings
Time frame: 6 weeks
Mean nightly number of awakenings determined by fitness tracker
Rapid Eye Movement (REM) sleep (minutes)
Time frame: 6 weeks
Mean nightly minutes of REM sleep determined by fitness tracker
Light sleep (minutes)
Time frame: 6 weeks
Mean nightly minutes of light sleep determined by fitness tracker
Deep sleep (minutes)
Time frame: 6 weeks
Mean nightly minutes of deep sleep determined by fitness tracker
17 secondary outcomes
Albumin (g/dL)
Time frame: 6 weeks
Blood urea nitrogen (BUN) (mg/dL)
Time frame: 6 weeks
Creatinine (mg/dL)
Time frame: 6 weeks
Alkaline phosphatase (U/L)
Time frame: 6 weeks
Alanine transaminase (ALT) (U/L)
Time frame: 6 weeks
Aspartate aminotransferase (AST) (U/L)
Time frame: 6 weeks
Calcium (mg/dL)
Time frame: 6 weeks
Carbon Dioxide (mmol/L)
Time frame: 6 weeks
Chloride (mmol/L)
Time frame: 6 weeks
Potassium (mmol/L)
Time frame: 6 weeks
Sodium (mmol/L)
Time frame: 6 weeks
Total bilirubin (mg/dL)
Time frame: 6 weeks
Total protein (g/dL)
Time frame: 6 weeks
Safety/tolerability
Time frame: 6 weeks
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: 6 weeks
Short Form-20 (SF-20) scale
Time frame: 6 weeks
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Stevens, PhD principal investigator
doTERRA International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender essential oil-based product system in people with Healthy, run by dōTERRA International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: 6 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.