A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis |
Dietary Supplement: n-3 LC-PUFA Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid Arthritis |
- disease activity score DAS28 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- inflammatory markers (c-reactive protein, erythrocyte sedimentation rate) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- cellular and humoral immunological parameters (CDs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- COX expression [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- biomarkers of oxidative stress (8-iso-prostaglandin F2α, 15-keto-dh prostaglandin F2α, 8-oxo-deoxy-guanosine) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- hydroxypyridinium crosslinks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 45 |
| Study Start Date: | September 2004 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 35 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Germany | |
| 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 |
More Information
Publications:
| Responsible Party: | Prof. Dr. G. Jahreis, Universitiy of Jena |
| ClinicalTrials.gov Identifier: | NCT00638950 History of Changes |
| Other Study ID Numbers: | LSEP_H16-04 |
| Study First Received: | February 29, 2008 |
| Last Updated: | September 21, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Jena:
|
n-3 LC-PUFA Rheumatoid arthritis disease activity |
inflammation oxidative stress immune system |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013