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

Hofseth Biocare

Status: Active, not recruiting

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

Treatments: Dietary Supplement: Cod liver oil; Dietary Supplement: whole salmon oil

Study type: Interventional

Funder types: Industry

Identifiers

NCT06802068

HBC-CARDIO-2024-001-v2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

CARDIO salmon oil soft gel capsules

Active Comparator group

Description:

A minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon

Treatment:

Dietary Supplement: whole salmon oil

Omega-3 cod liver oil soft gel capsules

Active Comparator group

Description:

A standard, processed, concentrated omega-3 supplement

Treatment:

Dietary Supplement: Cod liver oil