Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005285

Trial Description

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Title

Food Chain Plus

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Trial Acronym

FoCus

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Overnutrition and obesity often are associated with inflammatory reaction in the human body. FoCus is a monozentric study with three major aims: (1) constitution of a cohort of 2000 healthy human probands for nutritional intervention studies, (2) development of functional food products with anti-inflammatory properties and (3) verification of the anti-inflammatory properties of the novel food products in the above mentioned cohort.
The functional foods will be tested in obese individuals who reciev either the functional food product or a placebo control.

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Brief Summary in Scientific Language

Inflammatory mechanisms are important in the development of nutrition associated diseases like obesity and type 2 diabetes. In the FoCus project it is aimed to develop functional food products with anti-inflammatory properties and to verify these properties in a novel cohort of 1500 cross sectional controls and 500 subjects with obesity.

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Organizational Data

  •   DRKS00005285
  •   2013/11/05
  •   [---]*
  •   yes
  •   Approved
  •   A156/03, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66 -  Obesity
  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   Chronic Inflammation
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Interventions/Observational Groups

  •   placebo
  •   functional food product (oligosaccharides and oligopeptides of milk), application in a once daily version over a time period of 4 weeks).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Interleukin-6, wnt5a and sFRP5 will be measured as biomarkers for inflammation at beginning, week 1, week 2, week 3 and at the end of the study by ELISA using probands serum samples.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/10/06
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

n=1500 cross sectional controls (govermental registration office), n=500 obesity (BMI > 30 kg/m2)

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Exclusion Criteria

non

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Addresses

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    • UKSH Universitätsklinikum Schleswig-Holstein
    • Arnold-Heller-Strasse 3
    • 24105  kiel
    • Germany
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    • UKSH, Campus Kiel Klinik für Innere Medizin 1
    • Mr.  Prof. Dr.  Matthias  Laudes 
    • Arnold Heller Strasse 3
    • 24105  Kiel
    • Germany
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    • UKSH, Campus Kiel Klinik für Innere Medizin 1
    • Mr.  Prof. Dr.  Matthias  Laudes 
    • Arnold Heller Strasse 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.