NCT02013466已完成1 期
Amino Acid Bioavailability in Healthy Elderly After Bolus Intake of a High Whey-protein, Leucine-rich, Low-caloric Oral Nutritional Supplement
Nutricia Research1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].
研究概览
简要总结
In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years or older
- •BMI between 21 and 30 kg/m2
排除标准
- •Any condition that may interfere with the definition 'healthy elderly' according to the investigator's judgement.
- •Any (history of) gastrointestinal disease that interferes with GI function (e.g. inflammatory bowel disease, gastroparesis, gastrectomy).
- •Known allergy to milk and milk products.
- •Known galactosaemia.
- •Current or recent (within past three months) smoking.
- •Known or suspected Diabetes Mellitus.
- •Current infection or fever in the last 7 days at the discretion of the physician.
- •Use of antibiotics within 3 weeks of study entry.
- •Current use of corticosteroids or hormones.
- •Current use of antacids or any medication influencing gastric acid production.
- •Requirement for any nutritional support.
- •Unplanned body weight loss > 5% in the past 3-6 months.
- •Adherence to any specific diet (e.g. weight loss, vegetarian).
- •Use of protein containing or amino acid containing nutritional supplements within one week of study entry.
- •Alcohol or drug abuse.
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- •Participation in any other study with investigational products concomitantly or within 4 weeks of study entry.
结局指标
主要结局
The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].
时间窗: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
次要结局
- Time to reach half the serum leucine iAUC (t½) [minutes].(Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Maximum serum essential amino acid concentration (EAAmax) [micromol/L](Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Serum leucine incremental area under the curve (iAUC) [micromol/L*min].(Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Maximum serum amino acid concentration (AAmax) [mmol/L](Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Maximum serum insulin concentration [micromol/L].(Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Serum insulin iAUC [micromol/L*min](Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Maximum serum glucose concentration [mmol/L](Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Serum glucose iAUC [mmol/L*min](Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits))
- Adverse events and (Gastro-Intestinal) tolerance questionnaire.(During the study and until one week after completion of the study)
研究者
研究点 (1)
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