A Study on the Effect of Consuming Marine Oils on Joint Stiffness and Joint Pain in Adults. A Randomised Double-blind Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Joint inflammation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (50-75 years)
- •Mild to moderate joint pain for at least 3 months
- •Stable body weight last 3 months
排除标准
- •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
研究组 & 干预措施
Herring oil
Dietary supplement: herring oil in capsules, regular content of omega-11 MUFAs and omega-3 PUFAs, 4 g oil daily for 6 months
干预措施: Herring oil (Dietary Supplement)
Omega-11 concentrate produced from herring oil
Dietary supplement: omega-11 concentrate in capsules, containing mainly omega-11 MUFAs and omega-3 PUFAs, 4 g oil daily for 6 months
干预措施: Omega-11 concentrate produced from herring oi (Dietary Supplement)
Control oil
Dietary supplement: control oil (fish oil) in capsules, containing omega-3 PUFAs but no omega-11 MUFAs, 4 g oil daily for 6 months
干预措施: Control oil (Dietary Supplement)
结局指标
主要结局
Joint inflammation
时间窗: 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.
次要结局
- Concentration of TNF-alpha in blood(Change between baseline, 3 months and endpoint (6 months).)
- 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).)
- 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))
- Serum concentration of LDL-cholesterol(Change between baseline, 3 months and endpoint (6 months))
- Serum concentration of HDL-cholesterol(Change between baseline, 3 months and endpoint (6 months))
- Change from baseline in percent body fat(Change between baseline, 3 months and endpoint (6 months))
- Serum concentrations of amino acid and their metabolites(Change between baseline and endpoint (6 months))
- Serum concentrations of one-carbon metabolites(Change between baseline and endpoint (6 months))
- Serum concentration of non-esterified fatty acids(Change between baseline, 3 months and endpoint (6 months))
- Erythrocyte sedimentation rate(Change between baseline, 3 months and endpoint (6 months))
- Serum concentration of anti-Cyclic Citrullinated Peptide(Change between baseline and endpoint (6 months))
- Serum concentration of rheumatoid factor(Change between baseline and endpoint (6 months))