Trial document





This trial has been registered retrospectively.
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  DRKS00004851

Trial Description

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Title

Fat excretion after intake of a polyglucosamine: an observational study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Overweight and obesity nowadays are very common. More than half of the adult population in Germany is considered overweight or obese refering to the Nationale Verzehrsstudie II. The most relevant nutritional factor for the development of overweight and obesity is dietary fat with its high enery density and low capacity of satiety.
A well established pharmacological principle is to avoid the resorption of fat in the intestine. Formoline L112 is a weight loss supplement based on an indigestable polymer extracted from crustacean. This biopolymer acts as a lipidbinder and fat is excreted before it can be absorbed. Although the mechanism is known the real amount of fat excreted has not been determined yet. Therefore this observational study should be conducted with 10 healthy volunteers, who aquired formoline L112 in a pharmacy. The first visit is scheduled on day -7 with an introduction into dietary assessment which should be written for the whole period. On day 0 the first stool sample is collected and the intake of the tablets started. Two tablets (500mg each) before lunch and 2 tablets before dinner should be taken daily. The second stool sample should be collected after the 7th day of intake. The fat amount in the stool samples are measured after extraction by weighing.

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Brief Summary in Scientific Language

Overweight and obesity nowadays are very common. More than half of the adult population in Germany is considered overweight or obese refering to the Nationale Verzehrsstudie II. The most relevant nutritional factor for the development of overweight and obesity is dietary fat with its high enery density and low capacity of satiety.
A well established pharmacological principle is to avoid the resorption of fat in the intestine. Formoline L112 is a weight loss supplement based on an indigestable polymer extracted from crustacean. This biopolymer(ß- 1,4- Polymer von D-Glucosamin und N-Acetyl-D-Glucosamin) acts as a lipidbinder and fat is excreted before it can be absorbed. Although the mechanism is known the real amount of fat excreted has not been determined yet. Therefore this observational study should be conducted with 10 healthy volunteers. The first visit is scheduled on day -7 with an introduction into dietary assessment which should be written for the whole period. On day 0 the first stool sample is collected and the intake of the tablets started. Two tablets (500mg each) before lunch and 2 tablets before dinner should be taken daily. The second stool sample should be collected of the 7th day of intake. The fat amount in the stool samples are measured after extraction by weighing.

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Organizational Data

  •   DRKS00004851
  •   2014/07/21
  •   [---]*
  •   yes
  •   Approved
  •   322/13, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   obesity
  •   E66 -  Obesity
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Interventions/Observational Groups

  •   formoline L112: 2 tablets (500mg each) before lunch and 2 tablets before dinner over a period of 6 days; collection of fecal samples and analysis of fat amount/fatty acid pattern
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Fat excretion in the faeces is measured at the beginning and at the end of the 6-days intake.
Fat is extracted by HCL and weighed afterwards.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/01/30
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   70   Years
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Additional Inclusion Criteria

BMI 25 – 35 kg/m2, Stable bodyweight (± 2 kg in the last 3 months), wirtten informed consent

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Exclusion Criteria

severe general disease, present obstipation, congestion, known to be allergic to crustacean or to another ingredient, gut surgery mentioned in the anamnesis, psychiatric disorders

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Addresses

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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
    • Mr.  Prof. Dr. med.  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85350  Freising-Weihenstephan
    • Germany
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    • Lehrstuhl für Analytische LebensmittelchemieTU München
    • Mr.  Professor  Michael  Rychlik 
    • Alte Akademie 10
    • 85350  Freising
    • Germany
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
    • Ms.  Dipl oec troph  Yu-Mi  Lee 
    • Gregor-Mednel-Str. 2
    • 85350  Freising-Weihenstephan
    • Germany
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    •   08161-712007
    •   08161-712097
    •   ylee at wzw.tum.de
    •   [---]*
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lehrstuhl für Ernährungsmedizin
    • Ms.  Dipl oec troph  Yu-Mi  Lee 
    • Gregor-Mendel-Straße 2
    • 85350  Freising-Weihenstephan
    • Germany
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Sources of Monetary or Material Support

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    • Certmedica International GmbH
    • Magnolienweg 17
    • 63741  Aschaffenburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/04/17
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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.