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临床试验/NCT01943266
NCT01943266已完成不适用

Use of Indicator Amino Acid Oxidation Technique to Determine Protein Requirement of Elderly Male Subjects 65-75 Yrs Old.

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年3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
13
试验地点
2
主要终点
Urine (for measurement of 13C phenylalanine enrichment) and breath (for measurement of 13CO2 enrichment) samples will be collected on day 3 of the experiment between the 4th and 5th meal and after the 6th and 7th meal.

研究概览

简要总结

Minimal data are available on protein requirements throughout the lifespan. Currently available recommendations are based on nitrogen balance data. The limitations of the nitrogen balance method have been well described. Importantly, nitrogen balanced underestimates requirements.

The current dietary reference intakes (DRI) requirement for healthy adult males is based on the reanalysis of the nitrogen balance date from Young and Scrimshaw. This data was reanalyzed statistically by Rand et al. and he concluded that the protein requirement of healthy adults was 0.65 and 0.83 (mean and RDA) g/kg/day of good quality protein. Using indicator amino acid oxidation (IAAO), our group estimated the protein requirement of young men (mean age 27 years) to be 0.93 and 1.2 g/kg/day (mean and RDA).

Currently there are no studies on protein requirement in the elderly. In a recent nutrition survey conducted by national health and nutrition examination survey (NHANES), the authors concluded that adults between the ages of 51 - 70 years old consumed an average on 1.0 g/kg/day (ideal body weight) of protein which represents about 15 % of calories. Depending on the calculations used for ideal body weight some older adults could be getting higher or lower than requirement. There is no scientifically derived protein estimate for older adults. Therefore there is a need to measurer protein requirement in that population.

The goal of this study therefore is to measure the protein requirement of male elderly subjects between the ages of 65 - 75 years using the IAAO technique.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy elderly males between the ages of 65 to 75 years
  • Willingness to participate in the study
  • Males without a chronic disease or acute illness that could affect protein and AA metabolism eg, diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
  • Males with hypertension if well controlled by medications

排除标准

  • Presence of disease known to affect protein and amino acids (AA) requirement and synthesis like diabetes, cancer, liver o kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
  • On medications known to affect protein and amino acid metabolism like e.g. steroids.
  • Significant weight loss during the past month.
  • Individual on weight reducing diets.
  • Inability to tolerate the diet or unwilling to have blood drawn from a venous access for the purposes of the study.
  • Significant coffee consumption of more than 2 cups/day (400 mg of caffeine/day)
  • Significant Alcohol consumption of more than one drink/day ( 1 beer, ½ glass of wine)

研究组 & 干预措施

protein intake

Experimental

protein intake randomly fed from deficient to excess

干预措施: protein intake (Dietary Supplement)

结局指标

主要结局

Urine (for measurement of 13C phenylalanine enrichment) and breath (for measurement of 13CO2 enrichment) samples will be collected on day 3 of the experiment between the 4th and 5th meal and after the 6th and 7th meal.

时间窗: 10 months

次要结局

未报告次要终点

研究者

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

Dr. Paul Pencharz

Senior Scientist, The Research Institute, Hospital for Sick Children

The Hospital for Sick Children

研究点 (2)

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