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临床试验/NCT03571425
NCT03571425已完成不适用

The Impact of Enteral Versus Oral Protein Feeding on Muscle Protein Synthesis in Healthy Young Males and Females

University of Exeter2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年6月4日最近更新:
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
30
试验地点
2
主要终点
Postprandial muscle protein synthesis

研究概览

简要总结

The present study will seek to quantify the muscle protein synthetic response to a protein beverage consumed orally or through a nasogastric tube in healthy, young individuals.

详细描述

Thirty healthy, young volunteers will receive a stable isotope tracer infusion (8.5h) combined with repeated blood and muscle sampling, in order to measure muscle protein synthesis rate in the postabsorptive state, and following oral placebo ingestion (n=10), oral protein ingestion (n=10), or enteral protein administration (n=10).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

Oral conditions are double blinded to participant and investigator, but enteral vs oral feeding is not blinded

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-40 years of age
  • Body mass index between 18.5 and 30

排除标准

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
  • Any diagnosed cardiovascular disease
  • Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements)
  • Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism). This excludes oral contraceptives and contraceptive devices.
  • A personal or family history of epilepsy, seizures or schizophrenia.
  • Presence of an ulcer in the stomach or gut and/or strong history of indigestion
  • Known pre-existing liver disease/condition
  • Any known disorders in muscle metabolism
  • Regular use of nutritional supplements
  • Allergy to lidocaine
  • Allergy to milk
  • Current paracetamol use (i.e. use of paracetamol more than once a week)
  • Pregnancy

研究组 & 干预措施

Oral Placebo

Placebo Comparator

Placebo drink

干预措施: Oral Placebo (Other)

Oral Protein

Active Comparator

Protein drink, ingested orally

干预措施: Oral Protein (Other)

Enteral Protein

Active Comparator

Protein drink, administered via enteral tube

干预措施: Enteral Protein (Other)

结局指标

主要结局

Postprandial muscle protein synthesis

时间窗: 5 hours

Muscle protein synthesis rate (FSR) following ingestion of a placebo or protein supplement

次要结局

  • Postabsorptive muscle protein synthesis(2 hours)
  • Whole-body protein synthesis(7 hours)
  • Whole-body protein breakdown(7 hours)
  • Whole-body protein oxidation(7 hours)
  • Whole-body protein net balance(7 hours)
  • Gastric emptying rate(5 hours)
  • Blood glucose concentration(8.5 hours)
  • Serum insulin concentration(8.5 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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