Clinical trial NCT06802068: Change in Omega 3 Index in Healthy Adults with OmeGo or a Standard Omega-3 Oil Supplement
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health
Keywords: Omega-3 index, salmon oil CARDIO, omega-3 oil
Lead sponsor: Hofseth Biocare ASA
Sponsor class: INDUSTRY
First posted: 2025-01-30
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either a whole salmon oil supplement or a cod liver oil supplement.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-pregnant adults; 40-80 years of age; stable body weight prior 3 months

Exclusion Criteria:

* Fish or seafood allergies; Pregnant; already consuming fish oil supplementation; malabsorption states; malignancy in remission for less than 12 months; diabetic

Primary outcomes:
measure: To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Alethios
state: California
city: San Francisco
country: United States
facility: Alethios, Inc.
state: California
Study officials:
affiliation: HBC
name: Crawford Currie, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.