NCT06802068

Change in Omega 3 Index in Healthy Adults With OmeGo or a Standard Omega-3 Oil Supplement

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Hofseth Biocare ASA · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	whole salmon oil	A minimally processed whole salmon oil
DIETARY_SUPPLEMENT	Cod liver oil	Standard, processed omega-3 cod liver oil

Timeline

• Start date: 2025-02-18
• Primary completion: 2025-12-23
• Completion: 2026-01-05
• First posted: 2025-01-30
• Last updated: 2026-02-23

Locations

2 sites across 1 country: United States