Trial document




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  DRKS00008889

Trial Description

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Title

Effects of plant-extracts on diabetes mellitus (NID).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We aim to investigate wheter distinct extracts of plants can influence the human metabolism. We want to identify substances that are capable to improve the situation in humans with metabolic disorders in the absence of site effects.

To reach that we use methods of laboratory analytics.

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Brief Summary in Scientific Language

The influence oft plant-extracts with respect to metabolism has been discussed recently in the science world. These substances are available for the addition of nutrition yet.

Our goal is to prove the effectiveness in a scientific way. In this context we are especially interested in identifying ways to influence diabetes mellitus.

We want to optimize nutrition in order to prevent metabolic disorders.

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Organizational Data

  •   DRKS00008889
  •   2015/07/21
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  •   yes
  •   Approved
  •   14-250, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy Volunteer
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Interventions/Observational Groups

  •   Application of extracts (apple and cabbage blend) after baseline-measurement. Observation of blood-parameters (insulin, cortisol, glucose) before, after and in progression (every 10 minutes).
  •   Placebo-application (capsule with inert cellulose) after baseline-measurement. Observation of blood-parameters (insulin, cortisol, glucose) before, after and in progression (every 10 minutes).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Metabolic Parameters (insulin, cortisol, glucose) by using laboratory analytics. Before and after intervention vs. placebo.

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Secondary Outcome

Food intake. Before and after intervention. Procedure: Buffet-test.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/08/06
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   30   Years
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Additional Inclusion Criteria

No acute or chronic deseases. No medication.

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Exclusion Criteria

20 < BMI (Body-Mass-Index) > 25

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Sektion für Psychoneurobiologie, Universität Lübeck
    • Ms.  Prof.Dr.  Kerstin M.  Oltmanns 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Sektion für Psychoneurobiologie Universität Lübeck
    • Mr.  Jan Christian  Martens 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Sektion für Psychoneurobiologie Universität Lübeck
    • Mr.  Jan Christian  Martens 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Wirtschaft und Energie
    • Scharnhorststr. 34-37
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting planned
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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.