Effects of Maine Oils on Joint Stiffness and Pain

NCT07786181 | Not Yet Recruiting

• 1 other identifier: 987381
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

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.

  Change between baseline and endpoint (6 months)

Secondary Outcomes (14)

• Self-assessment of joint health using the RAID questionnaire

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

• Concentration of interleukin-6 in blood

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

• Concentration of TNF-alpha in blood

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

• Quantification of fatty acid contents in leucocytes

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

• Serum concentration of total cholesterol

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

Study Arms (3)

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

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

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

Dietary Supplement: Control oil

Interventions

Herring oil DIETARY_SUPPLEMENT

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

Herring oil

Omega-11 concentrate produced from herring oi DIETARY_SUPPLEMENT

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

Omega-11 concentrate produced from herring oil

Control oil DIETARY_SUPPLEMENT

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

Control oil

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Oddrun A Gudbrandsen, PhD

CONTACT

+4755585421; nkjgu@uib.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 25, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share