Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults

NCT ID: NCT06364163

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2027-12-31

Brief Summary

High cholesterol concentration is a major risk factor for cardiovascular disease (CVD), and consumption of fish has been associated with a lower CVD risk in several studies. The beneficial health effects of consuming fish have traditionally been ascribed to the long-chain PUFA (LC-PUFA) EPA (C20:5n-3) and DHA (C22:6n-3), although consumption of fish oils or concentrates with high EPA and DHA contents does not affect the cholesterol concentration in humans and lowers the cholesterol concentration in rats and mice only when given in very high doses. Fish oils contain a plethora of fatty acids besides EPA and DHA, and in recent years, increased focus has been on the long-chain MUFA (LC-MUFA) cetoleic acid (C22:1n-11). Cetoleic acid is found in high amounts in oils from certain fish species such as herring, which has relatively low contents of both EPA and DHA. The investigators have recently summarised and meta-analysed the available literature that investigates the effects of diets containing fish oils or fish oil concentrates that have a high content of cetoleic acid but low or no content of EPA and DHA on cholesterol concentration in rodents, showing that cetoleic acid-rich fish oils and concentrates prevent high cholesterol concentration.

Conditions

High Cholesterol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Herring oil concentrate

Dietary supplement: herring oil concentrate in capsules, 4 g oil daily for 8 weeks

Group Type: EXPERIMENTAL

Herring oil concentrate

Intervention Type: DIETARY_SUPPLEMENT

Capsules containing herring oil concentrate, taken daily for 8 weeks.

Control oil

Dietary supplement: control oil in capsules, 4 g oil daily for 8 weeks

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Capsules containing control oil, taken daily for 8 weeks.

Interventions

Herring oil concentrate

Capsules containing herring oil concentrate, taken daily for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Control

Capsules containing control oil, taken daily for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• BMI over 25 kg/m2
• Stable body weight last 3 months

Exclusion Criteria

• Allergies towards fish, milk, egg, gluten
• Tobacco use (cigarettes or snus)
• Diseases affecting the heart, intestinal function, kidney function or insulin secretion
• Use of medications targeting cholesterol -or glucose metabolism
• Use of dietary supplements
• Pregnant or breastfeeding
• Following a strict diet
• Had bariatric surgery or using medications for weight loss
• Recent or planned surgical procedures
• High intake of fish/seafood

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Norwegian Seafood Research Fund

UNKNOWN

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Oddrun Anita Gudbrandsen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Bergen

Bergen, , Norway

Countries

Norway

Other Identifiers

697716

Identifier Type: -

Identifier Source: org_study_id