Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA
      supplemented products (sausage, tomato spread, milk beverage) on disease activity,
      inflammatory markers, and cardiovascular risk factors in patients with rheumatoid arthritis.
    

Detailed description: 
      Recent studies suggest that the daily intake of n-3 LC-PUFA (eicosapentaenoic acid (EPA) and
      docosahexaenoic acid (DHA)) can support the therapy of chronic-inflammatory diseases and
      might be useful to prevent coronary heart diseases. The majority of these studies do not
      differentiate between the effects of EPA and DHA. The present study investigate the
      therapeutic potential of DHA in patients with rheumatoid arthritis.

      As a precondition for participating in this study, the patients were provided information in
      writing and verbally form about the details of the study. Written informed consent was
      obtained from all volunteers. Before the beginning of the study, all patients were subject to
      a medical examination by their general rheumatologist. Thirty-eight patients with rheumatoid
      arthritis (DAS ≥ 2.4) entered the study.

      The placebo-controlled, randomized double-blind cross-over study consists of two
      investigation periods of 10 weeks, with a ten-week washout period in between (after the
      washout period the intervention was crossed between the groups and the respective products
      were consumed for further 10 weeks).

      Patients in the placebo period receive 60 g sausage, 8 g tomato spread and 30 g milk powder
      (= 200 mL milk beverage) daily. These products were enriched with sunflower oil (8 g/d).

      In the intervention period, the products (60 g sausage, 8 g tomato spread and 30 g milk
      powder (= 200 mL milk beverage) were enriched with 8 g microalgae oil (Schizochytrium sp.,
      Maris DHA oil, no. 3790, IOI, Hamburg, Germany). In this group, the daily dose of
      docosahexaenoic acid (DHA) amounted to 2.11 g.

      Venous blood is collected at the beginning and at the end of each period.

      • Disease activity was determined by sum of tender and swollen joints (68/66), joint score
      DAS28, ultrasound score (US-7 score), rheumascan, inflammatory markers (ESR, C reactive
      protein), HAQ questionnaire and further lifestyle forms
    

Intervention name(s): long-chain n-3 PUFA; sunflower oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement: n-3 LC-PUFA = Microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany (rich in docosahexaenoic acid (DHA)); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: included in 60 g sausage, 8 g tomato spread, 30 g milk powder; Dietary supplement: sunflower oil Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
Other intervention name(s): n-3 LC-PUFA; placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: n-3 LC-PUFA, DHA, rheumatoid arthritis