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

October 6, 2015 updated by: Gerhard Jahreis, University of Jena

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Jena, Germany, 07743
        • Friedrich Schiller University, Clinic for Internal Medicine
    • Thuringia
      • Jena, Thuringia, Germany, 07743
        • Facility: 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sum of tender and swollen joints (68/66), disease activity score DAS 28, ultrasound score US-7
Time Frame: 10 weeks
Disease activity parameters
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Inflammation markers such as erythrocyte sedimation rate (ESR), C reactive protein (CRP), adhesion molecules, cytokines, rheumascan
Time Frame: 10 weeks
Further disease acitvity parameters
10 weeks
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)
10 weeks
Lipid mediators formed by lipoxygenases, cyclogenases
Time Frame: 10 weeks
Lipidmediators derived from arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid
10 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
10 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jena

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Federal Ministry of Education and Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gerhard Jahreis, Professor, Friedrich Schiller University Jena, Department 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H53-12

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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