Effects of Maine Oils on Joint Stiffness and Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorUniversity of Bergen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Herring oilExperimental treatment 1 intervention
Group B: Omega-11 concentrate produced from herring oilExperimental treatment 1 intervention
Group C: Control oilActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change between baseline and endpoint (6 months)

Secondary outcomes

1

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.

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

Leucocytes are isolated from heparine blood.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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