NL-OMON49959已完成不适用
Real-time Amino acid Profiling - 2 - RAP-2 study
FrieslandCampina Research0 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
- 发起方
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •* 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
- •* 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
- •* 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 results and
- •eventual adverse events to and from his general practitioner
研究者
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