Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Impact of n-3 Polyunsaturated Fatty Acids on Adipose Tissue Inflammation in Morbidly Obese Patients

    Summary
    EudraCT number
    		 2006-005287-94
    Trial protocol
    		 AT  
    Global end of trial date
    20 Feb 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2020
    First version publication date
    30 Jul 2020
    Other versions
    Summary report(s)
    		 n-3 PUFA reduce adipose tissue inflammation in obesity

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Stulnig_PUFA1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00760760
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien
    Sponsor organisation address
    Währinger Gürtel 18-20, Wien, Austria, 1090
    Public contact
    Prof. Thomas M. Stulnig, Medizinische Universität Wien Departement of Medical III, +43 14040043100, thomas.stulnig@meduniwien.ac.at
    Scientific contact
    Prof. Thomas M. Stulnig, Medizinische Universität Wien Departement of Medical III, +43 14040043100, thomas.stulnig@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Feb 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    effect of n-3 polyunsaturated fatty acids (n-3 PUFA; Omacor®) on visceral and subcutaneous adipose tissue inflammation
    Protection of trial subjects
    The subjects were allocated to receive either Omacor or Butterfat as control. Both groups tolerated the intervention very well. During the trial oral glucose tolerance tests were performed without any complications. Adipose tissue samples were collected at the end of the trial during bariatric surgery unter general anesthesia.
    Background therapy
    		 -
    Evidence for comparator
    		 n-3 PUFA was supplied in 1 g gelatin capsules containing 90% ethyl esters of n-3 PUFA including 460 mg eicosapentaenoic acid and 380 mg docosahexaenoic acid as it is available as a drug ("Omacor"®). Four capsules were taken daily, i.e. 3,6 g n-3 PUFA per day. Butter was supplied as a control source of fatty acids in 10 g portions and patients were advised to take approximately one package within two days, i.e. 5 g daily, in addition to their usual diet. Since butter contains approximately 80% of fat, this dose approximately equals the daily dose of fatty acids administered with the n-3 PUFA capsules.
    Actual start date of recruitment
    27 Aug 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 62
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    62
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment was performed at the General Hospital from the Medical University of Vienna in Vienna, Austria. Patients who were scheduled to undergo bariatric surgery were screened for inclusion and exclusion criteria. If patients seemed eligible for inclusion in the trial they were contacted by investigators for the trial ans asked to participate.

    Pre-assignment
    Screening details
    		 Screening began in the summer of 2008 and a total of 148 patients were screened. Of these 54 patients did not meet inclusion criterial (mostly due to preexisting type 2 diabetes) and 32 patients declined to participate.

    Period 1
    Period 1 title
    Baseline period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 n-3 PUFA
    Arm description
    		 Patients treated with Omacor
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Omacor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 capsules per day

    Arm title
    		 Control
    Arm description
    		 Control treated patients receiving butterfat
    Arm type
    		 Placebo

    Investigational medicinal product name
    Butter
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral paste
    Routes of administration
    Oral use
    Dosage and administration details
    Butter was supplied as a control source of fatty acids in 10 g portions (Tiroler Teebutter) and patients were advised to take approximately one package within two days, i.e. 5 g daily, in addition to their usual diet. Since butter contains approximately 80% of fat, this dose approximately equals the daily dose of fatty acids administered with the n-3 PUFA capsules.

    Number of subjects in period 1
    		n-3 PUFA Control
    Started
    30
    32
    Completed
    27
    28
    Not completed
    3
    4
         Adverse event, non-fatal
    3
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    n-3 PUFA
    Reporting group description
    		 Patients treated with Omacor

    Reporting group title
    Control
    Reporting group description
    		 Control treated patients receiving butterfat

    Reporting group values
    		 n-3 PUFA Control Total
    Number of subjects
    		 30 32 62
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 30 32 62
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        62
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 25 25 50
        Male
    		 5 7 12

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    n-3 PUFA
    Reporting group description
    		 Patients treated with Omacor

    Reporting group title
    Control
    Reporting group description
    		 Control treated patients receiving butterfat

    Primary: inflammatory gene expression

    		 Close Top of page
    End point title
    		 inflammatory gene expression
    End point description
    Expression of inflammatory genes in adipose tissue at the end of the treatment was analyzed according to the delta delta Ct (ddCt) method, normalized to ubiquitin C, and expression levels were calculated as 2^(–ddCt). Data was presented as the mean (+/-SEM) of subcutaneous adipose tissue (SAT) from control subjects in percent. The mean of the SAT 2^(–ddCt) was set to 100%.
    End point type
    Primary
    End point timeframe
    at the end of the treatment periode
    End point values
    		 n-3 PUFA Control
    Number of subjects analysed
    23
    26
    Units: percent SAT control
    number (not applicable)
        CCL2
    69
    100
        CCL3
    62
    100
        IL6
    45
    100
        HIF1A
    78
    100
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    The statistical analysis included all patients who completed the trial and from which appropriate materials were obtained (n = 49) for adipose tissue and 55 for blood variables, except as otherwise indicated). Group differences between ddCt values in visceral adipose tissue (VAT) and SAT were analyzed by Student’s t test. Treatment effectiveness was considered achieved if statistical significance was demonstrated at the prespecified nominal a-level (0.05) for most of the primary endpoints.
    Comparison groups
    n-3 PUFA v Control
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 repeated measures ANOVA
    Parameter type
    		 time x treatment interaction
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Notes
    [1] - A reduction of the primary outcome variable by 50% (corresponding to a change of +1.0 in dCt values. dCt is the logarithmic measure of gene expression analysis by quantitative real-time PCR normalized to a control gene) was considered clinically significant.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    2008-2011
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Diabetes
    Reporting group description
    		 4 patients were diagnosed with new type 2 diabetes mellitus upon the OGTT performed at randomisation. They were subsequently excluxded from the trial.

    Serious adverse events
    		 Diabetes
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 62 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Diabetes
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 62 (6.45%)
    Endocrine disorders
    Diabetes mellitus
         subjects affected / exposed
    4 / 62 (6.45%)
         occurrences all number
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial has been conducted between 2008-2011. Since then many years have passed but all data sets are available, thus it is easy to identify all relevant information. The data has been published in the American Journal of Clinical Nutrition.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23034965
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 08:38:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA