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临床试验/DRKS00005481
DRKS00005481已完成未知

Comparison of two formula diets for weight reduction

eibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung0 个研究点目标入组 160 人开始时间: 2013年11月28日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
160

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
30 Years 至 65 Years(—)
性别
All

入选标准

  • 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

排除标准

  • - 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

研究者

发起方
eibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung

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