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

NCT06802068 | Completed

• 1 other identifier: HBC-CARDIO-2024-001-v2
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement

  Change in omega-3 index after 14 weeks supplementation

  18 weeks

Study Arms (2)

CARDIO salmon oil soft gel capsules

ACTIVE COMPARATOR

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

Dietary Supplement: whole salmon oil

Omega-3 cod liver oil soft gel capsules

ACTIVE COMPARATOR

A standard, processed, concentrated omega-3 supplement

Dietary Supplement: Cod liver oil

Interventions

whole salmon oil DIETARY_SUPPLEMENT

A minimally processed whole salmon oil

Also known as: CARDIO oil

CARDIO salmon oil soft gel capsules

Cod liver oil DIETARY_SUPPLEMENT

Standard, processed omega-3 cod liver oil

Omega-3 cod liver oil soft gel capsules

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hofseth Biocare ASA: lead

Study Sites (2)

Alethios

Menlo Park, California, 94025, United States

Location

Alethios, Inc.

San Francisco, California, 94109, United States

Location

Related Publications (1)

• 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.

  PMID: 30954305 BACKGROUND

MeSH Terms

Interventions

Cod Liver Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Fish Oils; Oils

Study Officials

• Crawford Currie, MBBS

  HBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either a whole salmon oil supplement or a cod liver oil supplement.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 30, 2025
• Study Start: February 18, 2025
• Primary Completion: December 23, 2025
• Study Completion: January 5, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)