Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-07 @ 5:30 AM
Study NCT ID:
NCT06492694
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Supplement and Health Markers
Sponsor:
dÅTERRA International
Organization:
Study Overview
Official Title:
Evaluation of a Fish Oil-based, Essential-oil Infused Supplement on Markers of Health
Status:
COMPLETED
Status Verified Date:
2025-01
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 fish oil-based supplements can affect gene expression and serum protein markers in healthy volunteers. The main questions it aims to answer are:
1. How does daily ingestion of fish oil supplements affect gene expression, omega-3 levels, and protein markers as measured in blood?
2. How does daily ingestion of fish oil supplements affect anthropometric measurements?
3. How does daily ingestion of fish oil supplements affect subjective quality of life and health parameters?
4. Do fish oil + wild orange essential oil supplements produce different outcomes than fish oil supplements alone?
5. Is ingesting fish oil supplements daily safe, as measured by laboratory tests and adverse events?
Researchers will compare two types of fish oil supplements. One type contains fish oil and wild orange essential oil as its active ingredients. The other type contains only fish oil as its active ingredient.
Participants will:
* Be assigned one of the two types of fish oil supplements
* Take three softgels of their assigned supplement every day for about six weeks
* 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. How does daily ingestion of fish oil supplements affect gene expression, omega-3 levels, and protein markers as measured in blood?
2. How does daily ingestion of fish oil supplements affect anthropometric measurements?
3. How does daily ingestion of fish oil supplements affect subjective quality of life and health parameters?
4. Do fish oil + wild orange essential oil supplements produce different outcomes than fish oil supplements alone?
5. Is ingesting fish oil supplements daily safe, as measured by laboratory tests and adverse events?
Researchers will compare two types of fish oil supplements. One type contains fish oil and wild orange essential oil as its active ingredients. The other type contains only fish oil as its active ingredient.
Participants will:
* Be assigned one of the two types of fish oil supplements
* Take three softgels of their assigned supplement every day for about six weeks
* 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 adults to compare gene expression profile, omega-3 levels, and protein markers before and after consumption of fish oil supplements for approximately six 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:
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?: