Rheumatoid Arthritis Clinical Trial
Official title:
Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid Arthritis
The effects of n-3 LC-PUFA-supplemented dairy products on inflammation and immunological parameters, biomarkers of oxidative stress, serum lipids, and disease activity were determined in patients with rheumatoid arthritis (RA).
Recent studies suggest that n-3 LC-PUFA may improve cardiovascular and inflammatory
diseases.
As a precondition for participating in this study, the subjects were provided information in
writing and verbally about the details of the study. Informed consent was obtained from all
volunteers. Before the beginning of the study, all participants were subject to a medical
examination in the Clinic for Rheumatology (Internal Medicine III, Friedrich Schiller
University, Jena). The RA was diagnosed according to the 1987 revised criteria of the
American Rheumatism Association (ARA). Severity of disease activity was evaluated by using
the disease activity score DAS 28.
Forty five subjects (43 f, 2 m) were randomly divided into two groups to carry out a
double-blind, placebo-controlled cross-over study.
The study consisted of two investigation periods of 12 weeks, with an eight-week washout
period in between. Patients received about 40 g fat daily (200 g yoghurt with 3.8% fat, 30 g
cheese with about 50% fat in the dry matter, and 20-30 g butter). The milk fat was partially
exchanged by special oils with high amounts of eicosapentaenoic acid (EPA), docosahexaenoic
acid (DHA), and alpha linoleic acid (ALA). The daily dose of n-3 FA amounted to 2.4 g,
consisting of 1.1 g ALA, 0.7 g EPA, 0.1 g DPA, and 0.4 g DHA. The placebo products were
commercial dairy products with comparable fat contents.
Venous blood and 24h urine were collected at the beginning and at the end of each period.
The DAS 28 score was assessed at the beginning and the end of each period, respectively.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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