A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00638950|
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : September 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Dietary Supplement: n-3 LC-PUFA Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid Arthritis|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
The placebo products were commercial dairy products with comparable fat contents.
|Active Comparator: n-3 LC-PUFA||
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.
- disease activity score DAS28 [ Time Frame: 12 weeks ]
- inflammatory markers (c-reactive protein, erythrocyte sedimentation rate) [ Time Frame: 12 weeks ]
- cellular and humoral immunological parameters (CDs) [ Time Frame: 12 weeks ]
- COX expression [ Time Frame: 12 weeks ]
- biomarkers of oxidative stress (8-iso-prostaglandin F2α, 15-keto-dh prostaglandin F2α, 8-oxo-deoxy-guanosine) [ Time Frame: 12 weeks ]
- hydroxypyridinium crosslinks [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638950
|University of Jena, Institute of Nutrition, Department of Nutritional Physiology|
|Jena, Thuringia, Germany, 07743|
|Principal Investigator:||Gerhard Jahreis, Prof. Dr.||University of Jena, Dept. of Nutritional Physiology|