Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488417
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
Frankincense Supplements and Inflammation
Sponsor:
dōTERRA International
Organization:
dōTERRA International
Study Overview
Official Title:
Evaluation of Frankincense Essential Oil Supplements on Markers of Inflammation and Cellular Health
Status:
COMPLETED
Status Verified Date:
2024-08
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 frankincense essential oil-based supplements can affect gene expression and serum protein markers in healthy volunteers The main questions it aims to answer are
1 Do frankincense essential oil supplements affect gene expression and protein markers as measured in blood
2 How does daily ingestion of frankincense supplements affect anthropometric measurements including body mass index waist circumference blood pressure and heart rate
3 How does daily ingestion of frankincense essential oil supplements affect subjective quality of life and health parameters
4 Is ingesting frankincense essential oil supplements daily safe as measured by laboratory tests and adverse events
Researchers will compare two types of frankincense essential oil supplements One type contains frankincense essential oil and boswellic acid as its active ingredients The other type contains only frankincense essential oil as its active ingredient
Participants will
Be assigned one of the two types of frankincense essential oil supplement
Take two capsules of their assigned supplement every day for about 30 days
Attend two study visits in which they provide blood and urine samples complete subjective health and quality of life assessments and undergo anthropometric measurements
Complete weekly subjective health assessments from home
1 Do frankincense essential oil supplements affect gene expression and protein markers as measured in blood
2 How does daily ingestion of frankincense supplements affect anthropometric measurements including body mass index waist circumference blood pressure and heart rate
3 How does daily ingestion of frankincense essential oil supplements affect subjective quality of life and health parameters
4 Is ingesting frankincense essential oil supplements daily safe as measured by laboratory tests and adverse events
Researchers will compare two types of frankincense essential oil supplements One type contains frankincense essential oil and boswellic acid as its active ingredients The other type contains only frankincense essential oil as its active ingredient
Participants will
Be assigned one of the two types of frankincense essential oil supplement
Take two capsules of their assigned supplement every day for about 30 days
Attend two study visits in which they provide blood and urine samples complete subjective health and quality of life assessments and undergo anthropometric measurements
Complete weekly subjective health assessments from home
Detailed Description:
This randomized double-blind study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of frankincense essential oil supplements for approximately 4 weeks Quality of life will also 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?:
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?:
None