Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- DAS28 (Disease Activity Score 28-joint count)
研究概览
简要总结
Background: Patients with inflammatory rheumatic diseases (IRD) are prone to malnutrition for several reasons. The diseases and treatment can cause reduced intake and absorption of nutrients and the inflammatory processes may cause an increased demand for nutrients, especially proteins. Studies report that nutritional status can affect disease activity. Dietary supplement of 3-4 gram omega-3 has shown beneficial effect upon disease activity in patients with IRD.
Aim: To investigate whether improved dietary intake with and without supplements of omega-3 will affect disease activity in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA).
Hypothesis 1: A systematic change of diet in line with the Norwegian dietary guidelines, which will result in increased intake of, among other nutrients, omega-3 fatty acids and complete protein, as well as reduced intake of saturated fat and sugar, will improve nutritional status and reduce disease activity.
Hypothesis 2: A systematic change of diet (as above), included a high dose of omega-3 will further improve nutritional status and reduce disease activity compared with placebo.
Design: A DB-RCT-study will be conducted. All patients will receive individualized dietary guidance by a clinical dietician for 12 weeks, before randomization to supplements of omega-3 or placebo, for 24 weeks. The supplement will be blinded for the participants, researchers and physicians.
Clinical implications: The study will investigate the effect of improved diet and nutrition on treatment offered to patients with IRD to provide more evidence-based knowledge, and thus specific dietary guidelines for patients with IRD. In addition, the study might increase the understanding of the role of omega-3 in the pathogenesis of inflammation.
详细描述
The study is approved by the Regional Committee for Medical and Health Research Ethics. Participation is voluntary, and informed consent will be requested. Outpatients will be recruited by doctors at the Rheumatology Department at Haukeland University Hospital (HUH). Patients recruited will be included consecutively. The recruitment period will last up to 12 months. Anthropometrical measurements, analysis of body composition, blood tests, clinical parameters, and dietary data will be collected at baseline, and after 12, 24, 36 and 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed with one of the following diagnoses: rheumatoid arthritis, according to the ACR / EULAR 2010 criteria, psoriatic arthritis, according to the CASPAR criteria, axial spondylarthritis, including ankylosing spondylarthritis and non-radiographic spondylarthritis, according to the ASAS criteria
- •Duration of illness ≥0.5 years
- •Between 18 and 75 years
- •Understand Norwegian
- •The patient has given informed consent to participate
- •No change in medication the last 12 weeks before inclusion
排除标准
- •Diagnoses / conditions that make it difficult to follow a dietary intervention and / or supplementation of omega-3s, including:
- •Conditions or use of medications where omega-3 is contraindicated
- •Pregnancy / lactation
- •Allergy to soy or fish
- •Severe liver disease
- •Severe mental or physical illnesses, such as insulin-requiring diabetes
结局指标
主要结局
DAS28 (Disease Activity Score 28-joint count)
时间窗: Change between week 0, 12, 24, 36 and 52
Disease activity score, higher values indicate a higher disease activity and below 2.6 meaning remission.
DAPSA (Disease Activity Index for Psoriatic Arthritis)
时间窗: Change between week 0, 12, 24, 36 and 52
Disease activity score, higher values indicate a higher disease activity and below 4 meaning remission
ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)
时间窗: Change between week 0, 12, 24, 36 and 52
Disease activity score, higher values indicate a higher disease activity
次要结局
- Handgrip strength(Change between week 0, 12, 24, 36 and 52)
- Body composition(Change between week 0, 12, 24, 36 and 52)
- BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)(Change between week 0, 12, 24, 36 and 52)
- BASFI (Bath Ankylosing Spondylitis Functional Index)(Change between week 0, 12, 24, 36 and 52)
- Dietary intake of macro- and micronutrients, based on a 24h recall.(Week 0, 12, 24, 36, 52)
- Blood lipid profile(Change from week 0, 12, 24, 36 and 52)
- Waist circumference(Change between week 0, 12, 24, 36 and 52)
- MHAQ (Modified Health Assessment Questionnaire)(Change between week 0, 12, 24, 36 and 52)
- CDAI (Clinical Disease Activity Index)(Change between week 0, 12, 24, 36 and 52)
- Dietary intake of macro- and micronutrients, based on a dietary registration of 7 days(Week -1,10, 50)
- RAID (Rheumatoid Arthritis Impact of Disease)(Change between week 0, 12, 24, 36 and 52)
- RAND12 (short form health survey)(Change between week 0, 12, 24, 36 and 52)
- Consumption of medicine after 12 months(Change between baseline and week 52)
- BMI (Body Mass Index)(Change between week 0, 12, 24, 36 and 52)