跳至主要内容
临床试验/NL-OMON51846
NL-OMON51846已完成不适用

Bioequivalence of a diabetes specific tube feed with a new carbohydrate source - EquiDia

utricia Research0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)

入选标准

  • 1. Age >= 18 and <= 65 years
  • 2. Body Mass Index (BMI) >= 18.5 and <= 27.0 kg/m2
  • 3. Written informed consent
  • 4. Willingness and ability to comply with the protocol
  • 5. Judged by the Investigator to be in good health

排除标准

  • 1. Known Diabetes Mellitus type I or type II, rebound hypoglycaemia and/or any
  • other medical condition that
  • 2. Any use of anticoagulants, systemic steroids, protease inhibitors or
  • antipsychotics and/or any medication known to affect glucose tolerance and/or
  • to influence digestion and absorption of nutrients within 1 week of screening,
  • in opinion of the Investigator
  • 3. Any known disease which influences digestion and absorption of nutrients
  • within 1 week of screening (in the opinion of the Investigator)
  • 4. Allergy to soy and/or any other known relevant food allergy or intolerance
  • in opinion of the Investigator
  • 5. Adherence to a strict vegan diet
  • 6. Adherence to a weight loss program
  • 7. Picky/fussy eater (being very selective about what to eat) or eating disorder
  • 8. Known pregnancy and/or lactation
  • 9. Current smoking or stopped smoking for < 1 month prior to screening (except
  • for incidental smoking of <= 3 cigarettes/cigars/pipes per week on average in
  • the last month)
  • 10. Average alcohol use of > 21 glasses per week for men or > 14 glasses per
  • week for women (on average during the last 6 months)
  • 11. Drug or medicine abuse in opinion of the Investigator
  • 12. Any known bleeding disorder
  • 13. Active participation in any other clinical study with investigational or
  • marketed products concomitantly or within 4 weeks before study visit 1, in the
  • opinion of the Investigator
  • 14. Major medical or surgical event requiring hospitalization within the
  • preceding 3 months and/or scheduled in the period of study participation
  • relevant in the opinion of the Investigator
  • 15. Investigator*s uncertainty about the willingness or ability of the subject
  • to comply with the protocol requirements
  • 16. Employees of Nutricia Research and/or family members or relatives of

研究者

发起方
utricia Research

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