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

September 21, 2011 updated by: University of Jena

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease activity score DAS28
Time Frame: 12 weeks
12 weeks
inflammatory markers (c-reactive protein, erythrocyte sedimentation rate)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
cellular and humoral immunological parameters (CDs)
Time Frame: 12 weeks
12 weeks
COX expression
Time Frame: 12 weeks
12 weeks
biomarkers of oxidative stress (8-iso-prostaglandin F2α, 15-keto-dh prostaglandin F2α, 8-oxo-deoxy-guanosine)
Time Frame: 12 weeks
12 weeks
hydroxypyridinium crosslinks
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Investigators

  • Principal Investigator: Gerhard Jahreis, Prof. Dr., University of Jena, Dept. of Nutritional Physiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSEP_H16-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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