Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000325

Trial Description

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Title

Effectiveness of a multilateral weight reduction conception

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The goal of this study in terms of nutritional physiology is to examine the effects of a combined nutritional procedure (protein-rich formula diet combined with fatbinding tablets) in connection with diet and sport instructions on weight reduction and selected parameters in obese persons (BMI 28-35 kg/m²).

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Brief Summary in Scientific Language

This study examines the effects of a combined nutritional procedure composed of a protein-rich formula diet as a meal replacement combined with lipidbinding tablets (Polyglucosamine L112) in connection with diet and sport instructions on weight reduction and selected parameters (lipid and glucose metabolism) in obese persons (BMI 28-35 kg/m²).

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Organizational Data

  •   DRKS00000325
  •   2010/02/01
  •   [---]*
  •   no
  •   Approved
  •   09/2638, Freiburger Ethik-Kommission International
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Secondary IDs

  •   U1111-1113-5324 
  •   003/09  (Studiennummer)
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Health Condition or Problem studied

  •   E66.0 -  Obesity due to excess calories
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   verum group: intake of two fatbinding tablets per day
  •   Placebo group: intake of two placebo tablets per day
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Other
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

body weight, BMI at any appointment (week 0, week 6, week 12, week 18)

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Secondary Outcome

waist circumference, Bioelectrical impedance analysis, blood pressure, several blood parameters (e.g. glucose, insulin, TC, HDL, LDL, TG), questionnaire at any appointment (week 0, week 6, week 12, week 18)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/12/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- caucasian men and women at the age of 30-60 years
- Body Mass Index between 28,0 and 35,0 kg/m²
- proband's written agreement to investigation after oral and written education about study content, demands and risks
- proband's willingness to replace one meal by a formula diet and to consume two fatbinding tablets per day
- proband's willingness to follow the given recommendations concerning nutrition and physical acitvity

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Exclusion Criteria

- severe chronic illness (manifest chd, cancer)
- insulin-dependent diabetes mellitus Typ I and II
- severe kidney or liver diseases
- chronic gastroinestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas) and state after gastrointestinal surgical procedure e.g. nontropical sprue, short bowel syndrome)
- stomach stapling operations, gastric band
- known endokrine and immunological diseases
- lactose malabsorption
- intolerance towards soy and milk protein
- continuous intake of laxatives
- continuous intake of corticosteroids (not inhalation), psychotropic drugs
- pregnancy
- lactation
- addiction to alcohol and/or drugs
- immediate planned surgery
- simultaneous participation at another clinical trial or participation within the last 30 days
- missing consent
- refusing / reset of the consent

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Addresses

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    • Leibniz Universität Hannover Institut für Lebensmittelwissenschaft und Ökotrophologie Abteilung Ernährungsphysiologie und Humanernährung
    • Mr.  Prof. Dr.  Andreas  Hahn 
    • 30167  Hannover
    • Germany
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    • Leibniz Universität Hannover Institut für Lebensmittelwissenschaft und Ökotrophologie Abteilung Ernährungsphysiologie und Humanernährung
    • Mr.  Prof. Dr.  Andreas  Hahn 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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    • Leibniz Universität Hannover Institut für Lebensmittelwissenschaft und Ökotrophologie Abteilung Ernährungsphysiologie und Humanernährung
    • Ms.  Janina  Postler 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Certmedica International GmbH
    • Magnolienweg 17
    • 63741  Aschaffenburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/06/30
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Trial Publications, Results and other Documents

  •   Hahn A, Postler J (2011): Multifactorial intervention for weight loss, obesity reviews 12, Suppl. 1, S. 278
  •   Plötz S, Postler J, Hahn A (2011): Effectiveness of a multilateral weight reduction conception on cardiovascular risk factors, obesity reviews 12, Suppl. 1, S. 205
  •   Willers J, Plötz S, Hahn A (2012): The combination of a high-protein formula diet and polyglucosamine decreases body weight and parameters of glucose and lipid metabolism in overweight and obese men and women, European Journal of Food Research & Review. 2, 1, S. 29-45
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* This entry means the parameter is not applicable or has not been set.