Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510335
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Lavender Essential Oil-based Product System for Sleep
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None