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NCT Number: NCT07786181

Effects of Maine Oils on Joint Stiffness and Pain

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.

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Key information

Conditions

Joint Pain Arthralgia Joint Diseases Joint Function Joint Stiffness Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (50-75 years)
  • Mild to moderate joint pain for at least 3 months
  • Stable body weight last 3 months

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Herring oil

Dietary Supplement

Capsules containing herring oil concentrate, taken daily for 6 months.

Omega-11 concentrate produced from herring oi

Dietary Supplement

Capsules containing omega-11 concentrate, taken daily for 6 months

Control oil

Dietary Supplement

Capsules containing a control oil, taken daily for 6 months.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Self-assessment of joint health using the RAID questionnaire

    Time frame: Change between baseline, 3 months and endpoint (6 months)

    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.

  2. Concentration of interleukin-6 in blood

    Time frame: Change between baseline, 3 months and endpoint (6 months).

  3. Concentration of TNF-alpha in blood

    Time frame: Change between baseline, 3 months and endpoint (6 months).

  4. Quantification of fatty acid contents in leucocytes

    Time frame: Change between baseline, 3 months and endpoint (6 months)

    Leucocytes are isolated from heparine blood.

  5. Serum concentration of total cholesterol

    Time frame: Change between baseline, 3 months and endpoint (6 months)

    Total cholesterol is measured in fasting samples

  6. Serum concentration of LDL-cholesterol

    Time frame: Change between baseline, 3 months and endpoint (6 months)

    LDL-cholesterol is measured in fasting samples

  7. Serum concentration of HDL-cholesterol

    Time frame: Change between baseline, 3 months and endpoint (6 months)

    HDL-cholesterol is measured in fasting samples

  8. Change from baseline in percent body fat

    Time frame: Change between baseline, 3 months and endpoint (6 months)

    Percent body fat will be measured using bioimpedance

  9. Serum concentrations of amino acid and their metabolites

    Time frame: Change between baseline and endpoint (6 months)

  10. Serum concentrations of one-carbon metabolites

    Time frame: Change between baseline and endpoint (6 months)

  11. Serum concentration of non-esterified fatty acids

    Time frame: Change between baseline, 3 months and endpoint (6 months)

  12. Erythrocyte sedimentation rate

    Time frame: Change between baseline, 3 months and endpoint (6 months)

  13. Serum concentration of anti-Cyclic Citrullinated Peptide

    Time frame: Change between baseline and endpoint (6 months)

  14. Serum concentration of rheumatoid factor

    Time frame: Change between baseline and endpoint (6 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Oddrun A Gudbrandsen, PhD

CONTACT

[email protected]

+4755585421

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study 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.

Acronym: MAR-LEDD

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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