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临床试验/NL-OMON28579
NL-OMON28579已完成不适用

Real-time Amino acid Profiling 2

FrieslandCampina Nederland BV0 个研究点目标入组 12 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
入组人数
12

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

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • Age =65 and =80
  • BMI =20 and =32 kg/m2
  • Non-smoking
  • Healthy as assessed by the NIZO lifestyle and health questionnaire (Verklaring leefgewoonten en gezondheid”) and according to the judgment of the study physician.
  • Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
  • Veins suitable for cannulation (blood sampling)
  • Voluntary participation
  • Having given written informed consent
  • Willing to comply with study procedures
  • Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.
  • Accept disclosure of the financial benefit of participation in the study to the authorities concerned

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study
  • Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer
  • Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
  • Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (> 7 mmol/l in finger prick blood) as assessed during screening visit
  • For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb <7,5 mmol/l
  • Use of protein supplements
  • Mental status that is incompatible with the proper conduct of the study
  • A self-reported reported food allergy or sensitivity to dairy ingredients
  • Alcohol consumption for men > 28 units/week and >4/day; for women: >21 units/week and >3/day
  • Reported unexpected weight loss or weight gain of > 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period
  • Reported slimming or medically prescribed diet
  • Recent blood donation (<1 month prior to Day 01 of the study)
  • Not willing to give up blood donation during the study
  • Personnel of NIZO food research and FrieslandCampina, their partner and their first and second degree relatives
  • Not having a general practitioner
  • Not willing to accept information-transfer concerning participation in the study, or information regarding his or her health, like laboratory

研究者

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