Trial document




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  DRKS00008729

Trial Description

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Title

Influence oft prebiotics and probiotics on gut colonization, weight, lipid profile and blood sugar levels in overweight adults

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The intestinal microbiota has several
effects on the hosts health. Studies suggest
that it may be related to the presence of obesity and metabolic diseases like diabetes. The study wants to examine the effect of a prebiotic-probiotic-preparation on weight, blood lipids and blood sugar levels.
Probiotics are living bacterias which are intended to colonize the large intestine and confer physiological health benefits to the host. Prebiotics are dietary supplements which can modulate the microbiota in a healthy way.
We believe that the application of one of the two study drugs leads to greater weight loss, a more pronounced reduction in blood sugar and the triglyceride and cholesterol levels than the placebo.

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Brief Summary in Scientific Language

Several human intervention studies have been performed that have demonstrated that consumption of certain pre- or probiotics can result in statistically significant changes in the composition of the gut microbiota. It is known, that the gut microbiota influences body weight, blood sugar levels and lipid profile.
In this study comparisons of the microbiota, body weight, blood sugar, levels, lipid profiles should be made among 20 obese individuals, which receive one of two synbiotics for 12 weeks to 10 obese individuals, who receive a placebo.

Study hypothesis: UK-Darmflora or the new preparation are superior to placebo in terms of weight reduction, lowering of blood sugar and the triglyceride and cholesterol levels

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Organizational Data

  •   DRKS00008729
  •   2015/06/29
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  •   no
  •   Approved
  •   17615, Coburg - Ethikkommission der Hochschule Coburg, Friedrich-Streib-Straße 2, 96450 Coburg
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Secondary IDs

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Health Condition or Problem studied

  •   E66.90 -  [generalization E66.9: Obesity, unspecified]
  •   E11.90 -  [generalization E11.9: Non-insulin-dependent diabetes mellitus; Without complications]
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Interventions/Observational Groups

  •   Placebo (identical capsules containing silica) for twelve weeks
  •   UK Darmflora, (PZN-00477512)
    Inulin, Lactobacillus acidophilus, Lactobazillus rhamnosus, Lactobazillus casei, Bifidobakterium bifidum for twelve weeks
  •   Preparation with inulin, pectin, resistant starch, Lactobacillus plantarum, Lactobacillus gasseri, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium lactis, Bifidobacterium breve for twelve weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

weight loss after 4, 8 and 12 weeks

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Secondary Outcome

blood sugar reduction after 4, 8 and 12 weeks

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2015/07/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

participants: pre-obese (BMI 25 - 29,9) and obese (BMI ≥ 30)

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Exclusion Criteria

Immunosuppression, inflammatory bowel diseases, pregnancy, therapy with antibiotics

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Postapotheke
    • Mr.  Rudolf  Keil 
    • Auf dem Wiler 30
    • 41517  Grevenbroich
    • Germany
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    • Hochschule Coburg
    • Ms.  Prof. Dr.  Michaela  Axt-Gadermann 
    • Friedrich-Streib-Straße 2
    • 96450  Coburg
    • Germany
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    • Hochschule Coburg
    • Ms.  Prof. Dr.  Michaela  Axt-Gadermann 
    • Friedrich-Streib-.Str. 2
    • 96450  Coburg
    • Germany
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Sources of Monetary or Material Support

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    • Post Apotheke
    • Mr.  Rudolf   Keil 
    • Auf dem Wiler 30
    • 41517  Grevenbroich
    • 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.