Intervention With Long-chain n-3 Polyunsaturated Fatty Acids From Microalgae Oil in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01742468|
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : October 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Dietary Supplement: long-chain n-3 PUFA Dietary Supplement: sunflower oil||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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
- Sum of tender and swollen joints (68/66), disease activity score DAS 28, ultrasound score US-7 [ Time Frame: 10 weeks ]Disease activity parameters
- Inflammation markers such as erythrocyte sedimation rate (ESR), C reactive protein (CRP), adhesion molecules, cytokines, rheumascan [ Time Frame: 10 weeks ]Further disease acitvity parameters
- Concentrations of arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid in plasma lipids and erythrocyte lipids [ Time Frame: 10 weeks ]Precursors of eicosanoids (leukotriens, prostaglandins, thromboxanes) and docosanoids (resolvines)
- Lipid mediators formed by lipoxygenases, cyclogenases [ Time Frame: 10 weeks ]Lipidmediators derived from arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid
- Blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triacylglycerol (TAG), ox LDL, lipoprotein a) [ Time Frame: 10 weeks ]Cardiovascular risk factors
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): NCT01742468
|Facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology|
|Jena, Thuringia, Germany, 07743|
|Friedrich Schiller University, Clinic for Internal Medicine|
|Jena, Germany, 07743|
|Principal Investigator:||Gerhard Jahreis, Professor||Friedrich Schiller University Jena, Department of Nutritional Physiology|