Trial document




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  DRKS00005481

Trial Description

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Title

Comparison of two formula diets for weight reduction

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Overweight is a major health problem in Germany and other industrialized nations. It promotes the risk of many diseases such as type 2 diabetes, high blood pressure and hardening of the arteries. An integral part of the strategy to the preventive of lifestyle diseases is the reduction of body weight. Proven components in the treatment of obesity are formula diets as meal replacements.

This study examines the effects of a nutritional procedure (protein-rich formula diet or carbohydrate-rich formula diet) in obese persons (body mass index 28-35 kg/m²). In the first two weeks of the study, three meals a day will be replaced by the formula diet. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day for four weeks.
Therefore, the goal of this study is to achieve weight reduction in obese people by using formula diets as meal replacements. Additionally to weight reduction the intervention should be associated with improvements in lipid and carbohydrate metabolism.


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Brief Summary in Scientific Language

Overweight or obesity is a major and growing health problem in Germany and other industrialized nations. It elevates the risk of many diseases such as type 2 diabetes, hypertension and atherosclerosis. Therefore, an integral part of the strategy with regard to the preventive and therapeutic measures against lifestyle diseases is the reduction of body weight. Established meal replacement strategies using formula diets are used to prevent obesity.
This study examines in terms of nutritional physiology the effects of a nutritional procedure composed of a protein-rich or carbohydrate-rich formula diet, which replaces three meals per day for the first two weeks. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day for four weeks.

The goal of the intervention is a general weight reduction and improvements of selected parameters (lipid and glucose metabolism) in obese persons (BMI 28-35 kg/m²). The group which takes the carbohydrate formula diet obtains a non-inferior effect relative to the protein-rich diet.


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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005481
  •   2013/11/28
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  •   no
  •   Approved
  •   Bo/39/2013, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   Group 1: intake of protein-rich formula diet


    In the first two weeks participants have to replace all three meals a day by the formula diet. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day (depending on the daily schedule) for four weeks.

    A protein-rich meal replacement consists of two serving spoons (about 34g) of powder and 300 ml low-fat milk and 5 g of vegetable oil.
  •   Group 2: intake of carbohydrate-rich formula diet

    In the first two weeks participants have to replace all three meals a day by the formula diet. The next two weeks follows the replacement of two meals and finally should be replaced one meal by formula diet per day (depending on the daily schedule) for four weeks.

    A carbohydrate-rich meal replacement consists of two serving spoons (about 30g) of powder and 300 ml low-fat milk and 5 g of vegetable oil.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

body weight, waist circumference at any appointment (week 0, week 2, week 8, week 20)

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Secondary Outcome

body mass index (BMI), Bioelectrical impedance analysis, blood pressure, waist, waist to hip ratio several blood parameters (e.g. glucose, insulin, total cholesterol (TC),high-density-lipoprotein (HDL), low-density-lipoprotein (LDL), triglyceride (TG), Immunological parameters (hsCRP), questionnaire at any appointment (week 0, week 2, week 8, week 20)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/02/10
  •   160
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- caucasian men and women at the age of 30-65 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 coronary heart disease, 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
-Hormonal disorders, for example, hyperthyroidism and Cushing's syndrome
-Treatment with non-insulin-releasing antidiabetics (guar, acarbose)
-Acute potassium-and magnesium-deficient
- lactose or fructose malabsorption
- intolerance towards soy and milk protein
- continuous intake of laxatives
- existing intolerances or allergies to ingredients of the diet (eg nuts, wheat)
- 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 Humanernährung, 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 Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
    • Ms.  M.Sc.  Katharina  Möller 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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    • Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
    • Ms.  M.Sc.  Katharina  Möller 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Certmedica International GmbH
    • Mr.  Dr.  Kurt  Raisch 
    • Magnolienweg 17
    • 63741  Aschaffenburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/10
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Trial Publications, Results and other Documents

  •   Möller K, Willers J, Hahn A (2015): Efficacy of high carbohydrate versus high protein meal replacements on weight reduction - a randomized controlled trial, J Obes Weight Loss Ther 5: 266. doi: 10.4172/2165-7904.1000266
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* This entry means the parameter is not applicable or has not been set.