High CholesterolNCT06364163
Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults
A study testing Herring oil concentrate in people with High Cholesterol, run by University of Bergen at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Cholesterol
- What is being tested?
- Herring oil concentrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 12 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI over 25 kg/m2
- Stable body weight last 3 months
Who cannot join
- 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
Show all 10Show fewer
- Following a strict diet
- Had bariatric surgery or using medications for weight loss
- Recent or planned surgical procedures
- High intake of fish/seafood
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Effect of Consuming a Herring Oil Concentrate on LDL Cholesterol Concentration in Adults With Overweight or Obesity
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
- Being tested
- Herring oil concentrate, Control
- Keywords
- Cholesterol, Cetoleic acid
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herring oil concentrateDietary supplement
Capsules containing herring oil concentrate, taken daily for 8 weeks.
ControlDietary supplement
Capsules containing control oil, taken daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Herring oil concentrate | Experimental | Dietary supplement: herring oil concentrate in capsules, 4 g oil daily for 8 weeks Receives: Dietary Supplement: Herring oil concentrate |
| Control oil | Placebo comparator | Dietary supplement: control oil in capsules, 4 g oil daily for 8 weeks Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of LDL-cholesterol
LDL-cholesterol will be measured in fasting serum samples
Measured: 8 weeks
Secondary outcomes (9)
Serum concentration of HDL-cholesterol
HDL-cholesterol will be measured in fasting serum samples
Measured: 8 weeks
Serum concentration of total cholesterol
Total cholesterol will be measured in fasting serum samples
Measured: 8 weeks
Serum concentrations of apolipoproteins
Lipoproteins will be measured in fasting serum samples
Measured: 8 weeks
Serum concentrations of amino acids metabolites
Metabolites of amino acids will be measured in fasting serum samples
Measured: 8 weeks
Serum concentration of one-carbon pathway metabolites
Metabolites in the one-carbon pathway will be measured in fasting serum samples
Measured: 8 weeks
Fatty acid composition in leukocytes
Leukocytes will be isolated from fasting serum before quantification of fatty acids
Measured: 8 weeks
Serum concentration of glucose
Glucose will be measured in serum sampled in fasting condition
Measured: 8 weeks
Serum concentration of insulin
Insulin will be measured in serum sampled in fasting condition
Measured: 8 weeks
Body composition
Percent body fat will be measured using bioimpedance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start12 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Seafood Research Fund
- Responsible party
- Principal investigator, Oddrun Anita Gudbrandsen, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364163
- Sponsor's protocol ID
- 697716
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of Consuming a Herring Oil Concentrate on LDL Cholesterol Concentration in Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06364163
- Acronym / sponsor ID
- 697716
- Conditions
- High Cholesterol
- Keywords
- Cholesterol, Cetoleic acid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Norwegian Seafood Research Fund
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herring oil concentrate | Experimental | Dietary Supplement: Herring oil concentrateDietary supplement: herring oil concentrate in capsules, 4 g oil daily for 8 weeks |
| Control oil | Placebo comparator | Dietary Supplement: ControlDietary supplement: control oil in capsules, 4 g oil daily for 8 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI over 25 kg/m2
- Stable body weight last 3 months
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herring oil concentrateCapsules containing herring oil concentrate, taken daily for 8 weeks. | Dietary supplement | Herring oil concentrate |
| ControlCapsules containing control oil, taken daily for 8 weeks. | Dietary supplement | Control oil |
Primary outcome
Serum concentration of LDL-cholesterol
Time frame: 8 weeks
LDL-cholesterol will be measured in fasting serum samples
9 secondary outcomes
Serum concentration of HDL-cholesterol
Time frame: 8 weeks
Serum concentration of total cholesterol
Time frame: 8 weeks
Serum concentrations of apolipoproteins
Time frame: 8 weeks
Serum concentrations of amino acids metabolites
Time frame: 8 weeks
Serum concentration of one-carbon pathway metabolites
Time frame: 8 weeks
Fatty acid composition in leukocytes
Time frame: 8 weeks
Serum concentration of glucose
Time frame: 8 weeks
Serum concentration of insulin
Time frame: 8 weeks
Body composition
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herring oil concentrate in people with High Cholesterol, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of LDL-cholesterol (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.