Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-02 @ 12:21 AM
Study NCT ID:
NCT06802068
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in Omega 3 Index in Healthy Adults with OmeGo or a Standard Omega-3 Oil Supplement
Sponsor:
Hofseth Biocare ASA
Organization:
Study Overview
Official Title:
A Randomized Controlled Clinical Trial Assessing the Impact of 14-week Natural Salmon Oil Supplementation (CARDIO®) on the Omega-3 Index Response and Cardiometabolic and Inflammatory Biomarkers in Healthy, Non-Pregnant Adults
Status:
RECRUITING
Status Verified Date:
2025-02
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:
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits of eating fresh fish. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on inflammation and oxidative stress, cholesterol and markers of risk of diabetes. Change in sleep metrics will also be assessed.
Detailed Description:
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits akin to eating fresh fish. This could be because contains many more fats than just EPA and DHA and these other fats have well defined health benefits such as oleic acid which is also abundant in olive oil. Alternatively this might be a result of significant processing needed to extract and concentrate the omega-3 fraction resulting in elevated levels of oxidation and free fatty acids, both of which are pro-inflammatory and would therefore impair the health benefits of omega-3. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on common drivers of inflammation and oxidative stress, blood cholesterol and markers of the risk of developing diabetes. Change in sleep metrics will also be assessed using both questionnaires and data from the hypnograms recorded by wearable device.
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?:
False
Is an FDA AA801 Violation?: