Trial document




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  DRKS00020788

Trial Description

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Title

The impact of dietary cholesterol and the gut microbiota on the intestinal lipid resorption and the systemic lipid metabolism

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of this trial is to investigate the impact of cholesterol in the food on the microorganisms in the gut. This cholesterol changes the composition of these microorganisms. After drinking a fat-cocktail with or without cholesterol we investigate changes in the absorption of fat from the food and also how this fat is converted in the body by analyzing blood parameters and feces.

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Brief Summary in Scientific Language

The aim of this trial is to investigate the impact of dietary cholesterol and the gut microbiome on the intestinal lipid resorption and the systemic lipid metabolism. To perform a comprehensive analysis fat cocktails either containing cholesterol or no cholesterol are applied to the subjects and blood lipid parameters and changes to the microbiome in the feces are assesssed.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00020788
  •   2020/02/27
  •   [---]*
  •   yes
  •   Approved
  •   380/18 S, 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

  •   E66 -  Obesity
  •   E78 -  Disorders of lipoprotein metabolism and other lipidaemias
  •   K63 -  Other diseases of intestine
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Interventions/Observational Groups

  •   At day 1 of the study the subjects will have their last regular meal at around 7 pm and will be asked to provide a stool sample. From this time on the subjects will be asked not to consume anything except non-caloric liquids until the end of the intervention the next day.
    At day 2 of the study the subjects will arrive at the facility in the morning and anthropometric (height, weight, hip size) data will be measured. Subsequently the subjects will then receive a fat cocktail (Fresubin® 5 kcal SHOT, Fresenius Kabi) with a dose of 35 g fat/m² body surface.This cocktails contains cholesterol (food grade, >95 % purity) with a dose of 250 mg/m² body surface. At the time points (in hours) -0.5; 0; 0.5; 1; 1.5; 2; 3; 4; 5; 6; 7; 8 blood samples will be taken from subjects. After this the subjects are not objected to fasting any more.
    At day 3 the subjects will be asked again to provide a stool sample.
  •   The sequence of days 1, 2 and 3 is identical to arm 1.
    In contrast, the subjects receive a fat cocktail (Fresubin® 5 kcal SHOT, Fresenius Kabi) in a dose of 35 g fat/m² body surface, which contains no cholesterol.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Blood:
Analysis of lipid species and bile acids using mass spectrometry.
Feces:
Analysis of bacterial communities using 16S rRNA sequencing. analysis of bile acids using mass spectrometry.
By merging those data we try to find a correlation between distinct microbiota species and blood-lipid parameters ands bile acids with respect to the dietary cholesterol.

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Secondary Outcome

The generated Data are merged to find a correlation between microbiota and the cholesterol load as single aim, therefore a secondary outcome cannot be defined in this case.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2020/06/01
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   40   Years
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Additional Inclusion Criteria

Age 20 to 40
written consent
Europeans
BMI 18-35 kg/m²
Women and Men (1:1)
vegetarians

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Exclusion Criteria

Missing written consent

active smokers

chronic diseases like:
chronic infection (e.g. HIV)
diagnosed liver diseases (e.g. HBV,HCV)
diagnosed diabetes mellitus
required to undergo dialysis

pregnant or breastfeeding women

active participation in other interventionstudies

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Addresses

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    • Technische Universität München, Wissenschaftszentrum Weihenstephan, Lehrstuhl für Molekulare Ernährungsmedizin
    • Mr.  Professer  Martin  Klingenspor 
    • Gregor Mendel Straße 2
    • 85354  Freising
    • Germany
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    • Technische Universität München, ZIEL Institute for Food & Health, Core Facility Humanstudien
    • Mr.  Prof.  Thomas  Skurk 
    • Gregor-Mendel-Str. 2
    • 85354  Freising
    • Germany
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    • Technische Universität München, Wissenschaftszentrum Weihenstephan, Lehrstuhl für Molekulare Ernährungsmedizin
    • Mr.  Professer  Martin  Klingenspor 
    • Gregor Mendel Straße 2
    • 85354  Freising
    • Germany
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    • Technische Universität München, Wissenschaftszentrum Weheinstephan, Lehrstuhl für Molekulare Ernährungsmedizin
    • Mr.  Akim  Strohmeyer 
    • Gregor Mendel Strasse 2
    • 85354  Freising
    • Germany
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Sources of Monetary or Material Support

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    • DFG Sonderforschungsbereich CRC 1371: Microbiome Signatures
    • Gregor-Mendel-Str. 2
    • 85354  Freising-Weihenstephan
    • Germany
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    • Else Kröner-Fresenius Zentrum für Ernährungsmedizin
    • Gregor-Mendel-Str. 2
    • 85354  Freising-Weihenstephan
    • Germany
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Status

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

  •   Approval of ethics committee
  •   study protocol
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* This entry means the parameter is not applicable or has not been set.