Trial document





This trial has been registered retrospectively.
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  DRKS00006211

Trial Description

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Title

Impact of diet-induced obesity on gut barrier integrity and metabolic diseases in healthy subjects

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Trial Acronym

DieGo - Dietary Intervention and Gut Barrier Function

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URL of the Trial

http://www.kem.wzw.tum.de/index.php?id=64

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Brief Summary in Lay Language

The present study investigates the short term effects of a high-fat diet on gut permeability. Aside, the project aims to examine the impact of the gut barrier function on obesity-associated metabolic dysfunctions in humans.

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Brief Summary in Scientific Language

The present study investigates the effect of high-fat diet on gut barrier integrity and possible interactions with the low-grade inflammation as a hallmark of diverse metabolic disorders. The effect of a 7 day-overfeeding on the gut permeability, gut microbiota, peripheral immune cell sub-populations and insulin resistance will be measured in 24 healthy men.

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Organizational Data

  •   DRKS00006211
  •   2014/06/11
  •   [---]*
  •   yes
  •   Approved
  •   5499/12, 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-associated metabolic diseases in healthy subjects
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Interventions/Observational Groups

  •   24 healthy male subjects (BMI less or equal 25 kg/m²) receive an individually adapted diet for seven days with an excess of 1000kcal/day in addition to their individual total energy requirement. The macronutrient composition consists of 48 EN% fat (predominantly saturated fatty acids), 34 EN% carbohydrates and 18 EN% protein. Gut permeability, changes in gut microbiota, insulin sensitivity, peripheral immune cell sub-populations, blood pressure, pulse, metabolic rate, body composition, weight, blood parameters (fasting glucose, fasting insulin, liver function, kidney function, electrolyte, lipid profile, DNA, inflammation marker) will be measured before, after and 2 weeks after intervention.
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Characteristics

  •   Interventional
  •   [---]*
  •   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

gut permeability (using polyethylene glycol and sugar absorption test), changes in gut microbiota, inflammation marker in plasma and in peripheral immune cell sub-populations.
[Timeframe: baseline, after 7–day intervention period, 14 days after intervention is terminated]

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Secondary Outcome

insulin sensitivity, body composition, basal metabolic rate, blood parameters (fasting glucose, fasting insulin, liver function, kidney function, electrolyte, lipid profile, DNA, inflammation marker), blood pressure, pulse, eating behavior.
[Timeframe: baseline, after 7-day intervention period, 14 days after intervention is terminated]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/04/30
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

BMI <= 25kg/m², stable weight during the last 3 months (+/-2kg); Non-smokers; Signed informed consent

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Exclusion Criteria

Severe general diseases, e.g. cancer, COPD, severe heart disease (e.g. pacemaker), progressive renal failure, severe psychiatric or neurological diseases; Diabetes; Continuous treatment with oral anticoagulants or antithrombotics (except ASS 100); Malabsorption syndromes; Autonomous neuropathy; Poor compliance; lactose intolerance, sucrose intolerance, sucralose intolerance; Lack of written informed consent

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Addresses

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Else Kröner-Fresenius-Zentrum für ErnährungsmedizinLehrstuhl für ErnährungsmedizinTechnische Universität München
    • Mr.  Professor  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85350  Freising-Weihenstephan
    • Germany
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    • Else Kröner-Fresenius-Zentrum für ErnährungsmedizinLehrstuhl für ErnährungsmedizinTechnische Universität München
    • Ms.  Beate  Ott 
    • Gregor-Mendel-Str. 2
    • 85350  Freising-Weihenstephan
    • 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 complete, follow-up complete
  •   2014/08/15
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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.