Joint PainMAR-LEDDNCT07786181
Effects of Maine Oils on Joint Stiffness and Pain
A study testing Herring oil and Omega-11 concentrate produced from herring oi in people with Joint Pain and Joint Stiffness, run by University of Bergen.
Trial summary
Joint pain has a negative effect on quality of life by limiting daily physical activity, and can lead to reduced work capacity, chronic stress, sleep problems, fatigue and reduced social life. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Pain, Joint Stiffness, Joint Function
- What is being tested?
- Herring oil and Omega-11 concentrate produced from herring oi
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to Dec 2031
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (50-75 years)
- Mild to moderate joint pain for at least 3 months
- Stable body weight last 3 months
Who cannot join
- Diagnosed reumatic disease
- Allergies towards fish, milk, egg, gluten
- Daily tobacco use (cigarettes or snus)
- Serious illness (cardiovascular disease, neurological disease, cancer, diseases affecting intestinal function, kidney function or insulin secretion)
- Use of medications targeting cholesterol or glucose metabolism
- Use of dietary supplements
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Effect of Consuming Marine Oils on Joint Stiffness and Joint Pain in Adults. A Randomised Double-blind Controlled Clinical Trial.
Joint pain has a negative effect on quality of life by limiting daily physical activity, and can lead to reduced work capacity, chronic stress, sleep problems, fatigue and reduced social life. Many people with joint pain find that taking fish oils reduces joint pain, and this may be related to an anti-inflammatory effect of omega-3 polyundaturated fatty acids (PUFAs). The investigators have recently shown that another group of fatty acids, that is, omega-11 monounsaturated fatty acids (MUFAs), have a strong anti-inflammatory effect in rats with chronic inflammation. Therefore, the investigators want to continue researching health effects of omega-11 MUFAs and investigate whether an anti-inflammatory effect can also be observed in people with joint pain. Omega-11 MUFAs including cetoleic acid (C22:1n-11) are found in high amounts in oils from certain fish species such as herring. In this study the effects of marine oils given as supplements (capsules) will be investigated in adults with joint pain, with particular focus on changes in pain and stiffness in joints and on levels of selected inflammation markers in blood samples. The study has three arms; one group receives herring oil with regular content of omega-11 MUFAs, one group receives herring oil with high content of omega-11 MUFAs, and a third group receives a commercail fish oil that does contain omega-11 MUFAs. The omega-3 content is similar in all intervention capsule types.
- Conditions
- Joint Pain, Joint Stiffness, Joint Function
- Being tested
- Herring oil, Omega-11 concentrate produced from herring oi, Control oil
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herring oilDietary supplement
Capsules containing herring oil concentrate, taken daily for 6 months.
Omega-11 concentrate produced from herring oiDietary supplement
Capsules containing omega-11 concentrate, taken daily for 6 months
Control oilDietary supplement
Capsules containing a control oil, taken daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Herring oil | Experimental | Dietary supplement: herring oil in capsules, regular content of omega-11 MUFAs and omega-3 PUFAs, 4 g oil daily for 6 months Receives: Dietary Supplement: Herring oil |
| Omega-11 concentrate produced from herring oil | Experimental | Dietary supplement: omega-11 concentrate in capsules, containing mainly omega-11 MUFAs and omega-3 PUFAs, 4 g oil daily for 6 months Receives: Dietary Supplement: Omega-11 concentrate produced from herring oi |
| Control oil | Active comparator | Dietary supplement: control oil (fish oil) in capsules, containing omega-3 PUFAs but no omega-11 MUFAs, 4 g oil daily for 6 months Receives: Dietary Supplement: Control oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint inflammation
Inflammation will be assessed using three approaches: (1) The number of tender and swollen joints among the 28 joints included in the DAS28, a validated disease activity measure for rheumatoid arthritis; (2) ultrasound findings in tender and/or swollen joints; and (3) circulating levels of the inflammatory markers TNF-alpha and IL-6. Both the joint examination and ultrasound assessment will be performed by a rheumatologist. Ultrasound-detected synovitis will be assessed using the EULAR-OMERACT semiquantitative scoring system, with grey-scale synovitis and power Doppler signal graded from 0 to 3, where 0 represents the lowest grade and 3 the maximum grade.
Measured: Change between baseline and endpoint (6 months)
Secondary outcomes (14)
Self-assessment of joint health using the RAID questionnaire
Study participants record their perceptions of their joint health, diet, and physical activity. A modified version of the validated Rheumatoid Arthritis Impact of Disease (RAID) questionnaire will be used to assess participants' self-reported joint health. The RAID comprises seven domains: pain, physical function, fatigue, sleep, physical well-being, emotional well-being, and coping. Each domain is rated on a 0-10 scale, with 0 indicating no symptoms and 10 representing the worst possible symptoms.
Measured: Change between baseline, 3 months and endpoint (6 months)
Concentration of interleukin-6 in blood
Measured: Change between baseline, 3 months and endpoint (6 months).
Concentration of TNF-alpha in blood
Measured: Change between baseline, 3 months and endpoint (6 months).
Quantification of fatty acid contents in leucocytes
Leucocytes are isolated from heparine blood.
Measured: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of total cholesterol
Total cholesterol is measured in fasting samples
Measured: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of LDL-cholesterol
LDL-cholesterol is measured in fasting samples
Measured: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of HDL-cholesterol
HDL-cholesterol is measured in fasting samples
Measured: Change between baseline, 3 months and endpoint (6 months)
Change from baseline in percent body fat
Percent body fat will be measured using bioimpedance
Measured: Change between baseline, 3 months and endpoint (6 months)
Serum concentrations of amino acid and their metabolites
Measured: Change between baseline and endpoint (6 months)
Serum concentrations of one-carbon metabolites
Measured: Change between baseline and endpoint (6 months)
Serum concentration of non-esterified fatty acids
Measured: Change between baseline, 3 months and endpoint (6 months)
Erythrocyte sedimentation rate
Measured: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of anti-Cyclic Citrullinated Peptide
Measured: Change between baseline and endpoint (6 months)
Serum concentration of rheumatoid factor
Measured: Change between baseline and endpoint (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786181
- Sponsor's protocol ID
- 987381
- Acronym
- MAR-LEDD
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of Consuming Marine Oils on Joint Stiffness and Joint Pain in Adults. A Randomised Double-blind Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT07786181
- Acronym / sponsor ID
- MAR-LEDD / 987381
- Conditions
- Joint Pain, Joint Stiffness, Joint Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 25 Aug 2026 (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.
Joint pain has a negative effect on quality of life by limiting daily physical activity, and can lead to reduced work capacity, chronic stress, sleep problems, fatigue and reduced social life. Many people with joint pain find that taking fish oils reduces joint pain, and this may be related to an anti-inflammatory effect of omega-3 polyundaturated fatty acids (PUFAs). The investigators have recently shown that another group of fatty acids, that is, omega-11 monounsaturated fatty acids (MUFAs), have a strong anti-inflammatory effect in rats with chronic inflammation. Therefore, the investigators want to continue researching health effects of omega-11 MUFAs and investigate whether an anti-inflammatory effect can also be observed in people with joint pain. Omega-11 MUFAs including cetoleic acid (C22:1n-11) are found in high amounts in oils from certain fish species such as herring. In this study the effects of marine oils given as supplements (capsules) will be investigated in adults with joint pain, with particular focus on changes in pain and stiffness in joints and on levels of selected inflammation markers in blood samples. The study has three arms; one group receives herring oil with regular content of omega-11 MUFAs, one group receives herring oil with high content of omega-11 MUFAs, and a third group receives a commercail fish oil that does contain omega-11 MUFAs. The omega-3 content is similar in all intervention capsule types.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Herring oil | Experimental | Dietary Supplement: Herring oilDietary supplement: herring oil in capsules, regular content of omega-11 MUFAs and omega-3 PUFAs, 4 g oil daily for 6 months |
| Omega-11 concentrate produced from herring oil | Experimental | Dietary Supplement: Omega-11 concentrate produced from herring oiDietary supplement: omega-11 concentrate in capsules, containing mainly omega-11 MUFAs and omega-3 PUFAs, 4 g oil daily for 6 months |
| Control oil | Active comparator | Dietary Supplement: Control oilDietary supplement: control oil (fish oil) in capsules, containing omega-3 PUFAs but no omega-11 MUFAs, 4 g oil daily for 6 months |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (50-75 years)
- Mild to moderate joint pain for at least 3 months
- Stable body weight last 3 months
Key exclusion criteria (11 listed)
- Diagnosed reumatic disease
- Allergies towards fish, milk, egg, gluten
- Daily tobacco use (cigarettes or snus)
- Serious illness (cardiovascular disease, neurological disease, cancer, diseases affecting intestinal function, kidney function or insulin secretion)
- Use of medications targeting cholesterol or glucose metabolism
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 oilCapsules containing herring oil concentrate, taken daily for 6 months. | Dietary supplement | Herring oil |
| Omega-11 concentrate produced from herring oiCapsules containing omega-11 concentrate, taken daily for 6 months | Dietary supplement | Omega-11 concentrate produced from herring oil |
| Control oilCapsules containing a control oil, taken daily for 6 months. | Dietary supplement | Control oil |
Primary outcome
Joint inflammation
Time frame: Change between baseline and endpoint (6 months)
Inflammation will be assessed using three approaches: (1) The number of tender and swollen joints among the 28 joints included in the DAS28, a validated disease activity measure for rheumatoid arthritis; (2) ultrasound findings in tender and/or swollen joints; and (3) circulating levels of the inflammatory markers TNF-alpha and IL-6. Both the joint examination and ultrasound assessment will be performed by a rheumatologist. Ultrasound-detected synovitis will be assessed using the EULAR-OMERACT semiquantitative scoring system, with grey-scale synovitis and power Doppler signal graded from 0 to 3, where 0 represents the lowest grade and 3 the maximum grade.
14 secondary outcomes
Self-assessment of joint health using the RAID questionnaire
Time frame: Change between baseline, 3 months and endpoint (6 months)
Concentration of interleukin-6 in blood
Time frame: Change between baseline, 3 months and endpoint (6 months).
Concentration of TNF-alpha in blood
Time frame: Change between baseline, 3 months and endpoint (6 months).
Quantification of fatty acid contents in leucocytes
Time frame: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of total cholesterol
Time frame: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of LDL-cholesterol
Time frame: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of HDL-cholesterol
Time frame: Change between baseline, 3 months and endpoint (6 months)
Change from baseline in percent body fat
Time frame: Change between baseline, 3 months and endpoint (6 months)
Serum concentrations of amino acid and their metabolites
Time frame: Change between baseline and endpoint (6 months)
Serum concentrations of one-carbon metabolites
Time frame: Change between baseline and endpoint (6 months)
Serum concentration of non-esterified fatty acids
Time frame: Change between baseline, 3 months and endpoint (6 months)
Erythrocyte sedimentation rate
Time frame: Change between baseline, 3 months and endpoint (6 months)
Serum concentration of anti-Cyclic Citrullinated Peptide
Time frame: Change between baseline and endpoint (6 months)
Serum concentration of rheumatoid factor
Time frame: Change between baseline and endpoint (6 months)
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 25 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Herring oil and Omega-11 concentrate produced from herring oi in people with Joint Pain and Joint Stiffness, run by University of Bergen.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Oddrun A Gudbrandsen, PhD (+4755585421, nkjgu@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint inflammation (time frame: Change between baseline and endpoint (6 months)). 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 25 Aug 2026.