Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011526

Trial Description

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Title

Meal trial of fiber-enriched products.

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Trial Acronym

enable WP2.4

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URL of the Trial

http://www.enable-cluster.de/index.php?id=208

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Brief Summary in Lay Language

Aim of the enable study is to investigate the effect of fiber rich food on hunger/satiety, metabolic risk, colonic metabolisation and the influence on the microbiome.
Participants are recruited from the enable Cluster, age 40-65 years old with an higher risk for metabolic syndrome.
Pacebo-controlled study.

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Brief Summary in Scientific Language

Aim of the enable study is to investigate the health effect of fiber rich food. Participants 40-65 years old and with a risk for the metabolic syndrome eating a fiber rich meal. Hunger/satiety, changes in metabolic parameters, colonic metabolisation and changes in the microbiome were analyzed after the meal. Request of the acceptance of the fiber rich products with questionnaires. Hunger and satiety were examined via an ad libitum buffet 4 hours after the meal.
Placebo-controlled study.

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Organizational Data

  •   DRKS00011526
  •   2017/02/14
  •   [---]*
  •   yes
  •   Approved
  •   529/16S, 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

  •   E88 -  Other metabolic disorders
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Interventions/Observational Groups

  •   20 participants, 40-65 years old, with metabolic risk factors, 50% men and 50% women.
    Crossover design (each participant is eating the intervention meal as well as the placebo meal)
    Products:
    1st meal: meat loaf + bread roll (fiber rich vs. placebo) produced by Rettenmaier & Söhne.
    2nd meal: Salamipizza (fiber rich vs. placebo) produced by Dr. Oetker.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

satiety after a fiber rich meal vs. placebo. Investigation with visuell analogue scales at the time 0, 30, 60, 90, 120, 150, 180, 210, 2140 min. and ad libitum buffet 4 h after the meal. Analyzing Ghrelin in the Plasma at the time 0, 30, 60, 120, 180, 240.

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Secondary Outcome

Alalysing changes with Isulin, Glucose and Glucagon after fiber rich meals vs. placebo at the time 0, 30, 60, 120, 180, 240 min.
Influence of fiber vs. placebo on the microbiome. Collection of stool to measure changes in the microbiome. Measurement of colon metabolization with H2-beathtest at the time 0, 30, 60, 90, 120, 150, 180, 210, 240 min.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/01/09
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- 40-65 years old
- declaration of consent
- waist circumferende > 88 cm bei Frauen und > 102 cm bei Männern
- Kaukasian

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Exclusion Criteria

- missing declaration of consent
- Participation on another intervention study
- pregnancy
- acute illness

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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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    • Fraunhofer-Institut für Verfahrenstechnik und Verpackung IVV
    • Mr.  Dr. -Ing.  Peter  Eisner 
    • Giggenhauser Str. 35
    • 85350  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
  •   2017/06/01
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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.