Determining the Optimal Ratio of Branched Chain Amino Acids in Medical Foods for Methylmalonic and Propionic Acidemias (MMA/PROP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- 13C Phenylalanine Oxidation
研究概览
简要总结
This study will evaluate the branched-chain amino acids (BCAA) ratio in the medical foods formulated for Methylmalonic and Propionic Acidemias (MMA/PROP) patients. We will recruit 6 healthy children between 6-10y (3 boys and 3 girls). They will be given amino acid-based shakes and protein free cookies. Using a minimally invasive stable isotope based technique, we will be able to determine the optimal ratio of BCAA to be added in the medical foods for the MMA/PROP subjects.
详细描述
Purpose:
The purpose of this study is to use the minimally invasive Indicator Amino Acid Oxidation (IAAO) method in healthy school-aged children to determine the optimal ratio of BCAA in current medical foods used by MMA/PROP subjects. We will recruit healthy children to test our hypothesis.
Hypothesis:
- The IAAO will be high (suggesting low protein synthesis) at high leucine levels and will be low (suggesting optimal protein synthesis) when leucine levels are reduced and at a better-balanced ratio of leucine to isoleucine and valine.
- Children will have low levels of urine excretion of isoleucine and valine, with high leucine urinary excretion, when given the high ratio of leucine to valine and isoleucine. With the reduction of leucine intake in the diet, the urinary concentration of both isoleucine and valine will normalize.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy school-aged children 6-10y
- •Normal weight
- •Normal eating habits
- •English speaking children
排除标准
- •Children under 6 years old, or over 10 years old.
- •Children who are currently ill, with a fever, cold, vomiting or diarrhea.
- •Children outside of normal weight parameters (3rd -85th percentiles for weight).
- •Children with claustrophobia.
- •Children currently or recently taking medication or antibiotics.
- •Children with food allergies.
- •Children who cannot speak, write and read in English
结局指标
主要结局
13C Phenylalanine Oxidation
时间窗: 8 hours
Breath and Urine samples will be collected during the study to measure 13C Phenylalanine oxidation
次要结局
- Urinary Branched Chain amino acids excretion(8 hours)
研究者
Rajavel Elango, PhD
Principal Investigator
University of British Columbia