Trial document




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  DRKS00009797

Trial Description

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Title

Phenotyping of different age cohorts for nutritional studies within the scope of the cluster "Enable - healthy food choices in all stages of life".

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Trial Acronym

enable (TPZ)

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URL of the Trial

http://www.enable-cluster.de/

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Brief Summary in Lay Language

Aim of the study is to phenotype people different ages from Freising, Germany. Especially consumers food preferences, behaviors and metabolic conditions will be characterized. Furthermore there has to develop strategies for healthier food-choices particular for groups at increased risks for diet-related diseases.

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Brief Summary in Scientific Language

There are no intervention planned in the phenotyping and study platform (project Z).
There will be 4 cohorts analyzed: Children aged 3-5, young adults aged 18-25, adults aged 40-65 and elderly aged 75-85. There will be several investigations like anamnesis and clinical examinations, functional assessment and routine clinical chemistry, body composition analysis, bioimpedance analysis, energy metabolism, spiroergometric measurement, sensory phenotyping by questionnaires, genotyping, odor and taste testing, faeces collection and genotyping and an assessment of dietary intake and lifestyle features.

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Organizational Data

  •   DRKS00009797
  •   2016/01/20
  •   [---]*
  •   yes
  •   Approved
  •   452/15s, 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

  •   diet-related metabolism dysfunction
  •   Prevention of cardiovascular diseases
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Interventions/Observational Groups

  •   children aged 3 - 5.

    Measurements:
    Anamnesis and clinical examinations,
    bioimpedance analysis,
    body composition analysis,
    energy metabolism,
    genotyping via salvia,
    metabolomics via urine,
    microbiomics via faeces,
    assessment of dietary intake and lifestyle features,
    movement measurement,
    odor and taste testing.
  •   young adults aged 18 - 25.

    Measurements:
    Anamnesis and clinical examinations,
    bioimpedance analysis,
    body composition analysis,
    energy metabolism,
    spiroergometric measurement,
    fasting glucose value,
    routine clinical chemistry,metabolomics and genotyping via blood,
    metabolomics via urine,
    microbiomics via faeces,
    assessment of dietary intake and lifestyle features,
    movement measurement and heart rate variability,
    odor and taste testing (in selected cases whole body magnetic resonance imaging).
  •   adults aged 40 - 65.

    Measurements:
    Anamnesis and clinical examinations,
    bioimpedance analysis,
    body composition analysis,
    energy metabolism,
    Spiroergometric measurement,
    fasting glucose value,
    routine clinical chemistry,metabolomics and genotyping via blood,
    metabolomics via urine,
    microbiomics via faeces,
    assessment of dietary intake and lifestyle features,
    movement measurement and heart rate variability,
    odor and taste testing (in selected cases whole body magnetic resonance imaging).
  •   Elderly aged 75 - 85.

    Measurements:
    Anamnesis and clinical examinations,
    bioimpedance analysis,
    body composition analysis,
    energy metabolism,
    ergospirometry,
    fasting glucose value,
    routine clinical chemistry,metabolomics and genotyping via blood,
    metabolomics via urine,
    microbiomics via faeces,
    assessment of dietary intake and lifestyle features,
    geriatric assessment,
    movement measurement and heart rate variability,
    odor and taste testing (in selected cases whole body magnetic resonance imaging).
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Phenotyping

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2016/03/16
  •   560
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   85   Years
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Additional Inclusion Criteria

• Children aged 3-5, coorparativeness of children and parents, normal weight, girls/boys, caucasian.
• Adolescents aged 18 - 25, coorparativeness, BMI 18-35 kg/m2, women/men, caucasian.
• Adults aged 40-65, coorparativeness, BMI 18-35 kg/m2, women/men, caucasian.
• Elderly aged 75-85, coorparativeness, no guardianship, women/men, iliving in private household, mobile, caucasian.

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Exclusion Criteria

Children aged 3-5:
missing cooperativeness of parents,
current participation in an intervention study, chronic disease (allergic asthma),
other metabolic and autoimmune diseases, genetic syndrome (e.g. Prader-Willi, Trisomie 21),
blood transfusion in the last 2 month.

Adolescents aged 18-25 and Adults aged 40-65:
missing cooperativeness,
current participation in an intervention study, smoker,
pregnancy,
chronic disease,
diabetes,
metabolic- and autoimmune disease,
untreatet endocrine disease,
myocardial infarction within the last 3 years, stroke within the last 3 years,
pacemaker,
untreatet hypertension >160/95 mmHg, coronary cardiopathy within the last 3 years, cancer within the last 3 years,
kidney disease requiring dialysis,
Parkinson disease,
liver disease,
stomach ulcer,
chronic lung disease with oxygen supply, circulatory disorder,
mental illness or neuroleptic desease,
immobile (chairbound),
unintentionally loss in weight in the last 3 month,
blood transfusion in the last 3 month

Elderly aged 75-85:
missing cooperativeness,
current participation in an intervention study, smoker,
chronic disease,
diabetes,
metabolic- and autoimmune disease, untreatet endocrine disease,
myocardial infarction within the last 3 years, stroke within the last 3 years, pacemaker, untreatet hypertension >150/95 mmHg, coronary cardiopathy within the last 3 years, cancer within the last 3 years,
kidney disease requiring dialysis,
Parkinson disease,
liver disease,
stomach ulcer,
chronic lung disease with oxygen supply, circulatory disorder mental illness or neuroleptic desease,
immobile (chairbound),
nursing case, unintentionally loss in weight >5% in the last 3 month,
blood transfusion in the last 3 month.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Lehrstuhl für Ernährungsmedizin der Technischen Universität München
    • Mr.  Prof  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85354  Freising
    • Germany
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    • Lehrstuhl für Ernährungsmedizin der Technischen Universität München
    • Mr.  Prof  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85354  Freising
    • Germany
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    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München
    • Ms.  Rachel  Rennekamp 
    • Gregor-Mendel-Str. 2
    • 85354  Freising
    • 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
  •   2018/08/31
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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.