Purpose

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.

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized to either a whole salmon oil supplement or a cod liver oil supplement.
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
CARDIO salmon oil soft gel capsules
A minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon
  • Dietary Supplement: whole salmon oil
    A minimally processed whole salmon oil
    Other names:
    • CARDIO oil
Active Comparator
Omega-3 cod liver oil soft gel capsules
A standard, processed, concentrated omega-3 supplement
  • Dietary Supplement: Cod liver oil
    Standard, processed omega-3 cod liver oil

Recruiting Locations

Alethios
Menlo Park 5372223, California 5332921 94025
Contact:
Zeenia Framroze
1-650-206-8006

Alethios, Inc.
San Francisco 5391959, California 5332921 94109
Contact:
Zeenia Framroze
zeenia@alethios.com

More Details

NCT ID
NCT06802068
Status
Recruiting
Sponsor
Hofseth Biocare ASA

Study Contact

Crawford Currie, MBBS
1-650-206-8006
cc@hofsethbiocare.no

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.