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临床试验/NCT02587156
NCT02587156已完成不适用

Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization

Bispebjerg Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Abundance of milk protein-bound amino acid labels in blood protein.

研究概览

简要总结

12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 70 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Males age 65-70
  • Independently dwelling
  • Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)
  • Non-diabetic
  • No organ disease
  • No back pain
  • Not regularly take any prescription drugs or dietary supplements, which can influence muscle protein synthesis
  • Alcohol intake below 21 units pr. week
  • No known arthrosclerosis

排除标准

  • 未提供

研究组 & 干预措施

Meal serving at high dietary protein

Experimental

Test the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day

干预措施: Meal serving at high dietary protein (Dietary Supplement)

Meal serving at high dietary protein

Experimental

Test the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day

干预措施: Meal serving (Dietary Supplement)

Meal serving at low dietary protein

Active Comparator

Test the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day

干预措施: Meal serving at low dietary protein (Dietary Supplement)

Meal serving at low dietary protein

Active Comparator

Test the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day

干预措施: Meal serving (Dietary Supplement)

结局指标

主要结局

Abundance of milk protein-bound amino acid labels in blood protein.

时间窗: Baseline to 240 min postprandial

Related to the trials conducted after 21 days of habituation to either high or low protein in the diet: After intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in liver-synthesized blood protein at 240 min.

次要结局

  • Leg phenylalanine rate of disappearance and appearance, net balance.(Baseline to 240 min postprandial)
  • Whole body phenylalanine rate of disappearance and appearance, net balance.(Baseline to 240 min postprandial)
  • The myofibrillar protein fractional synthesis rate(Baseline to 240 min postprandial)
  • Urea production.(Baseline to 240 min postprandial)
  • Fecal microbiota composition(Change from pre-intervention to 21 days and 22 days (21 intervention days habituation and the standardized trial meal on day 21))
  • Abundance of milk protein-bound amino acid labels in myofibrillar protein.(Baseline to 240 min postprandial)
  • Nitrogen and creatinine excreted in urine(21 days post intervention, 240 min postprandial and 24 hours post the day 21 trial day)
  • Adaptation of expression of proteins involved in muscle protein turnover(After 21 days of habituation to either a high or a low dietary protein intake.)
  • First pass splanchnic extraction of dietary protein-derived labeled phenylalanine.(Baseline to 240 min postprandial)
  • Response of expression of proteins involved in muscle protein turnover(Baseline, 60 min and 240 min postprandial)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grith Højfeldt

MSc. Human Biology - PhD student

Bispebjerg Hospital

研究点 (2)

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