A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638950
• Other study ID #: LSEP_H16-04
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: September 21, 2011
• Start date: September 2004
• Est. completion date: May 2005

Study information

• Verified date: February 2008
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 74 Years

Eligibility

Inclusion Criteria:

• Clear diagnosis of Rheumatoid Arthritis

• Patients receiving nonsteroidal anti-inflammatory drugs (NSAID) or corticosteroids (max. 15 mg/d) or both were eligible if dosage had been stable for at least 4 weeks before day 1 of the study and remained below this limit throughout the study

• Patients on disease-modifying antirheumatic drugs (DMARD) had to be on a constant dosage for at least 8 weeks before and throughout the study

Exclusion Criteria:

• Subjects with gastrointestinal or metabolic diseases, alcohol abuse, taking dietary supplements (e. g. fish oil capsules), known allergies or foodstuff indigestibility

• patient's request, serious infections, inadequate control of arthritis symptoms (over 50% increase of the number of swollen or tender joints), reinstitution of therapy with DMARD, or if patient compliance with the study protocol was doubtful.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• n-3 LC-PUFA
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. 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.
• Placebo
The placebo products were commercial dairy products with comparable fat contents.

Locations

Country	Name	City	State
Germany	University of Jena, Institute of Nutrition, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Dawczynski C, Schubert R, Hein G, Müller A, Eidner T, Vogelsang H, Basu S, Jahreis G. Long-term moderate intervention with n-3 long-chain PUFA-supplemented dairy products: effects on pathophysiological biomarkers in patients with rheumatoid arthritis. Br J Nutr. 2009 May;101(10):1517-26. doi: 10.1017/S0007114508076216. Epub 2009 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease activity score DAS28		12 weeks	Yes
Primary	inflammatory markers (c-reactive protein, erythrocyte sedimentation rate)		12 weeks	Yes
Secondary	cellular and humoral immunological parameters (CDs)		12 weeks	Yes
Secondary	COX expression		12 weeks	Yes
Secondary	biomarkers of oxidative stress (8-iso-prostaglandin F2a, 15-keto-dh prostaglandin F2a, 8-oxo-deoxy-guanosine)		12 weeks	Yes
Secondary	hydroxypyridinium crosslinks		12 weeks	Yes