Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults

NCT06364163 | Active Not Recruiting

• 1 other identifier: 697716
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Cholesterol; Cetoleic acid

Outcome Measures

Primary Outcomes (1)

• Serum concentration of LDL-cholesterol

  LDL-cholesterol will be measured in fasting serum samples

  8 weeks

Secondary Outcomes (9)

• Serum concentration of HDL-cholesterol

  8 weeks

• Serum concentration of total cholesterol

  8 weeks

• Serum concentrations of apolipoproteins

  8 weeks

• Serum concentrations of amino acids metabolites

  8 weeks

• Serum concentration of one-carbon pathway metabolites

  8 weeks

Study Arms (2)

Herring oil concentrate

EXPERIMENTAL

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

Dietary Supplement: Herring oil concentrate

Control oil

PLACEBO COMPARATOR

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

Dietary Supplement: Control

Interventions

Herring oil concentrate DIETARY_SUPPLEMENT

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

Herring oil concentrate

Control DIETARY_SUPPLEMENT

Capsules containing control oil, taken daily for 8 weeks.

Control oil

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• The Norwegian Seafood Research Fund: collaborator

Study Sites (1)

University of Bergen

Bergen, Norway

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 15, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)