Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-12 @ 4:42 AM
Study NCT ID:
NCT06510335
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2024-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lavender Essential Oil-based Product System for Sleep
Sponsor:
dÅTERRA International
Organization:
Study Overview
Official Title:
Evaluation of a Lavender-based Natural Product System for Sleep Support
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: