A Long-Term Moderate Intervention With n-3 LC-PUFA-Supplemented Dairy Products in Patients With Rheumatoid Arthritis - Full Text View

Sponsored by:	University of Jena
Information provided by:	University of Jena
ClinicalTrials.gov Identifier:	NCT00638950

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

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Long-Term Moderate Intervention With n-3 LC-PUFA-Supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid Arthritis

Further study details as provided by University of Jena:

Primary Outcome Measures:

disease activity score DAS28, inflammation biomarkers (CRP, ESR1h) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cellular and humoral immunological parameters (CD), COX expression, biomarkers of oxidative stress (8-iso-PGF2α, 15-keto-dh PGF2α, 8-oxodG), hydroxypyridinium crosslinks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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)

Intervention Details:

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. The placebo products were commercial dairy products with comparable fat contents.

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 EPA, DHA, and 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638950

Locations

Germany, Thuringia
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743

Sponsors and Collaborators

University of Jena

Investigators

Principal Investigator:

Gerhard Jahreis, Prof. Dr.

University of Jena, Dept. of Nutritional Physiology

More Information

Responsible Party:	Universitiy of Jena ( Prof. Dr. G. Jahreis )
Study ID Numbers:	LSEP_H16-04
Study First Received:	February 29, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00638950
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Jena:

n-3 LC-PUFA
Rheumatoid arthritis
disease activity

inflammation
oxidative stress
immune system

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases

Arthritis, Rheumatoid
Stress
Rheumatic Diseases
Inflammation

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009