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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:
The lavender essential oil-based product system contains three components: an essential oil blend, a topical stick, and a dietary supplement.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Stevens, PhD | doTERRA International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| doTERRA International | Pleasant Grove | Utah | 84062 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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.
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| 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 |
| 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 |
| D001523 |
| Mental Disorders |