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临床试验/NCT00972582
NCT00972582已完成1 期

Determination of the Tolerable Upper Limit of Leucine Intake in Adult Humans

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
5
试验地点
1
主要终点
Breath carbon dioxide production

研究概览

简要总结

When dietary amino acid supplements are consumed by humans they are normally in addition to their normal daily requirements. The investigators' laboratory played a leading role in defining the estimated average requirement (EAR) and the recommended dietary intake for the "essential" amino acids (Dietary Reference Intakes 2005). The other important but less well studied component of Dietary Reference Intakes (DRI) is - What is a safe upper limit of intake? The investigators now propose to determine the safe upper limits of the dietary essential amino acids. The recently published DRI (2005) defines the Tolerable Upper Intake Level (UL) as 'the highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population.' As intake increases above the UL, the potential risk of adverse effects may increase'. In this proposal, the investigators define a novel method to define the safe upper limit where the 'maximum oxidative potential' of an amino acid identifies the 'metabolic limit' to dispose the amino acid. Intakes of amino acid above this level will increase the potential for adverse effects to appear.

详细描述

The objective of the study will be to determine the 'metabolic limit' of leucine oxidation in healthy young men by:

A) Measuring leucine oxidation in response to short term (8 hr) graded excess leucine intake B) Correlating changes in leucine oxidation with changes in plasma concentrations of keto-isocaproic acid (KIC, the first breakdown product of leucine metabolism), other essential amino acids, ammonia, urea, creatinine, glucose, insulin, and electrolytes (sodium, potassium, chloride) to identify potential biomarkers C) Correlating changes in leucine oxidation with changes in urinary excretion of leucine and ketoisocaproic acid (KIC), urea and creatinine to identify potential biomarkers

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 18-35 years old

排除标准

  • Report a recent history of sudden weight loss
  • Have unusual dietary habits such as chronic consumption of caffeinated beverages or alcohol
  • Have any endocrine disorders
  • Are currently using any prescribed medications

结局指标

主要结局

Breath carbon dioxide production

时间窗: Study Visits 1-7 (-45min,-30min,-15min, +2.5hrs, +3hrs, +3.5Hrs +4hrs)

次要结局

  • Plasma(Study Visits 1-7 (Hourly))
  • Urine(Study Visits 1-7 (8hr timepoint))
  • VCO2(Study Visits 1-7 (after 5hr meal))

研究者

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

Dr. Paul Pencharz

Emeritus Scientist

The Hospital for Sick Children

研究点 (1)

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Upper Limit of Leucine Intake in Adults | 临床试验