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

NCT ID: NCT06802068

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2026-01-05

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to either a whole salmon oil supplement or a cod liver oil supplement.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CARDIO salmon oil soft gel capsules

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

Group Type ACTIVE_COMPARATOR

whole salmon oil

Intervention Type DIETARY_SUPPLEMENT

A minimally processed whole salmon oil

Omega-3 cod liver oil soft gel capsules

A standard, processed, concentrated omega-3 supplement

Group Type ACTIVE_COMPARATOR

Cod liver oil

Intervention Type DIETARY_SUPPLEMENT

Standard, processed omega-3 cod liver oil

Interventions

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whole salmon oil

A minimally processed whole salmon oil

Intervention Type DIETARY_SUPPLEMENT

Cod liver oil

Standard, processed omega-3 cod liver oil

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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CARDIO oil

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hofseth Biocare ASA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Crawford Currie, MBBS

Role: PRINCIPAL_INVESTIGATOR

HBC

Locations

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Alethios

Menlo Park, California, United States

Site Status

Alethios, Inc.

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30954305 (View on PubMed)

Other Identifiers

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HBC-CARDIO-2024-001-v2

Identifier Type: -

Identifier Source: org_study_id

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