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临床试验/NCT02522052
NCT02522052已完成不适用

Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

Göteborg University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
difference between disease activity score 28 (DAS28) after the diets

研究概览

简要总结

Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large proportion of patients with established disease have persistent high disease activity in spite of existing effective pharmacological treatment. Improved treatment is thus urgently needed, including alternative treatments in addition to optimal pharmacological therapy. The main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis) could decrease inflammation and disease activity in patients with established RA. A secondary goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to look at genetic polymorphisms in relation to long chain polyunsaturated fatty acids (LCPUFA) and inflammatory markers.

详细描述

Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large proportion of patients with established disease have persistent high disease activity in spite of existing effective pharmacological treatment. Improved treatment is thus urgently needed, including alternative treatments in addition to optimal pharmacological therapy. The main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis) could decrease inflammation and disease activity in patients with established RA. A secondary goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to look at genetic polymorphisms in relation to LCPUFA and inflammatory markers.

Diet and lifestyle are associated with chronic diseases such as cardiovascular diseases, cancer and diabetes. Here, evidence based dietary treatment guidelines are available. In contrast, for inflammatory diseases such as RA no dietary guidelines exist, reflecting the ambiguous evidence base. Many dietary components are related to the human immune system or to inflammation. Some are co-factors in immune- or inflammatory response, such as zinc. Others are antioxidants, eg selenium, vitamins E and C. RA has been associated with low serum concentrations of zinc, selenium, vitamins D and B6 although some of this may reflect inflammatory response. Dietary effects on RA symptoms have been reported for long chain fatty acids from fish and probiotics have shown to improve function in RA patients. As prebiotics reduce inflammation in other conditions, it may have positive effects also on RA. Most research on antioxidants has focused on single nutrients but a few dietary trials also have been conducted with mixed results. In sum, high-quality studies evaluating the effect of a combination of food items with indicative effects on RA are needed.

Blue mussels are rich in vitamins (B2 and B12) and minerals (iron, selenium and zinc) and contain the LCPUFA eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI 18-40 kg/m2,
  • disease duration >2 years,
  • DAS28 >3.0

排除标准

  • other Life-threatening disease,
  • pregnant,
  • lactating,
  • food intolerant or allergic to food included in the study.

结局指标

主要结局

difference between disease activity score 28 (DAS28) after the diets

时间窗: after 11 week intervention

Measured clinically

次要结局

  • difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets(after 11 week intervention)
  • Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets(after 11 week intervention)
  • Differences and changes in metabolites after the two diets(after 11 week intervention)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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