Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01742468
First received: December 3, 2012
Last updated: August 27, 2015
Last verified: August 2015
  Purpose

The study was performed to investigate the effects of a daily consumption of n-3 LC-PUFA supplemented products (sausage, tomato spread, milk beverage) on disease activity, inflammatory markers, and cardiovascular risk factors in patients with rheumatoid arthritis.


Condition Intervention
Rheumatoid Arthritis
Dietary Supplement: long-chain n-3 PUFA
Dietary Supplement: sunflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention With Products Enriched With Long Chain n-3 Polyunsaturated Fatty Acids (n-3 LC-PUFA) From Microalgae Oil in Patients With Rheumatoid Arthritis - Influence on Disease Activity and Inflammation Status

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Sum of tender and swollen joints (68/66), disease activity score DAS 28, ultrasound score US-7 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Disease activity parameters


Secondary Outcome Measures:
  • Inflammation markers such as erythrocyte sedimation rate (ESR), C reactive protein (CRP), adhesion molecules, cytokines, rheumascan [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Further disease acitvity parameters

  • Concentrations of arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid in plasma lipids and erythrocyte lipids [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Precursors of eicosanoids (leukotriens, prostaglandins, thromboxanes) and docosanoids (resolvines)

  • Lipid mediators formed by lipoxygenases, cyclogenases [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Lipidmediators derived from arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid


Other Outcome Measures:
  • Blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triacylglycerol (TAG), ox LDL, lipoprotein a) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Cardiovascular risk factors


Enrollment: 38
Study Start Date: February 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary supplement: n-3 LC-PUFA
Name: microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany; rich in docosahexaenoic acid (DHA); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
Dietary Supplement: long-chain n-3 PUFA
Dietary supplement: n-3 LC-PUFA = Microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany (rich in docosahexaenoic acid (DHA)); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: included in 60 g sausage, 8 g tomato spread, 30 g milk powder
Other Name: n-3 LC-PUFA
Placebo Comparator: Dietary supplement: sunflower oil
Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
Dietary Supplement: sunflower oil
Dietary supplement: sunflower oil Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
Other Name: placebo

Detailed Description:

Recent studies suggest that the daily intake of n-3 LC-PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) can support the therapy of chronic-inflammatory diseases and might be useful to prevent coronary heart diseases. The majority of these studies do not differentiate between the effects of EPA and DHA. The present study investigate the therapeutic potential of DHA in patients with rheumatoid arthritis.

As a precondition for participating in this study, the patients were provided information in writing and verbally form about the details of the study. Written informed consent was obtained from all volunteers. Before the beginning of the study, all patients were subject to a medical examination by their general rheumatologist. Thirty-eight patients with rheumatoid arthritis (DAS ≥ 2.4) entered the study.

The placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between (after the washout period the intervention was crossed between the groups and the respective products were consumed for further 10 weeks).

Patients in the placebo period receive 60 g sausage, 8 g tomato spread and 30 g milk powder (= 200 mL milk beverage) daily. These products were enriched with sunflower oil (8 g/d).

In the intervention period, the products (60 g sausage, 8 g tomato spread and 30 g milk powder (= 200 mL milk beverage) were enriched with 8 g microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany). In this group, the daily dose of docosahexaenoic acid (DHA) amounted to 2.11 g.

Venous blood is collected at the beginning and at the end of each period.

• Disease activity was determined by sum of tender and swollen joints (68/66), joint score DAS28, ultrasound score (US-7 score), rheumascan, inflammatory markers (ESR, C reactive protein), HAQ questionnaire and further lifestyle forms

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a diagnosis of RA (according to the ACR classification criteria, revised 2010) for at least 6 months prior to randomization.
  • Patient has a moderate disease activity as defined by disease activity score DAS28 ≥ 2.4
  • Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.
  • stable dosis of disease-modifying antirheumatic drugs within 4 weeks prior to randomization and presumably over the study periods (30 weeks).

Exclusion Criteria:

  • Intra-articular corticosteroids within 4 weeks prior to randomization or blood sample taking
  • Patients are permitted to receive either oral or parenteral glucocorticoids equivalent to ≤10 mg daily prednisone and nonsteroidal anti-inflammatory drug, if they have received a stable dose for at least 4 weeks prior to randomization and presumably over the study periods (30 weeks).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742468

Locations
Germany
Friedrich Schiller University, Clinic for Internal Medicine
Jena, Germany, 07743
Friedrich Schiller University, Institute of Nutrition
Jena, Germany, 07743
Sponsors and Collaborators
University of Jena
German Federal Ministry of Education and Research
  More Information

No publications provided

Responsible Party: Gerhard Jahreis, Professor, University of Jena
ClinicalTrials.gov Identifier: NCT01742468     History of Changes
Other Study ID Numbers: H53-12
Study First Received: December 3, 2012
Last Updated: August 27, 2015
Health Authority: Ethics committee of the medical faculty of the Friedrich Schiller University Jena: Germany

Keywords provided by University of Jena:
n-3 LC-PUFA, DHA, rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 31, 2015