About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults (50-75 years)
Mild to moderate joint pain for at least 3 months
Stable body weight last 3 months
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Herring oil
Dietary supplementCapsules containing herring oil concentrate, taken daily for 6 months.
Omega-11 concentrate produced from herring oi
Dietary supplementCapsules containing omega-11 concentrate, taken daily for 6 months
Control oil
Dietary supplementCapsules containing a control oil, taken daily for 6 months.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Concentration of interleukin-6 in blood
Concentration of TNF-alpha in blood
Quantification of fatty acid contents in leucocytes
Leucocytes are isolated from heparine blood.
Locations
Sponsors and contacts
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