NCT03547362已完成不适用
Real-time Amino Acid Profiling
NIZO Food Research2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年5月30日最近更新:
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
- 试验地点
- 2
- 主要终点
- Postprandial serum amino acid concentration
研究概览
简要总结
This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 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 results and eventual adverse events to and from his general practitioner
结局指标
主要结局
Postprandial serum amino acid concentration
时间窗: 0-300 min after consumption
Blood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products.
次要结局
未报告次要终点
研究者
研究点 (2)
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