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临床试验/NCT03339167
NCT03339167已完成不适用

Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Millet Protein, in Young Adult Men

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年11月11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
5
试验地点
2
主要终点
Metabolic availability of Lysine in millet

研究概览

简要总结

Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. In many of those countries, millet is the major cereal grain in the diet. The protein in millet is low in the essential amino acid lysine. Hence millet protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries.

As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of millet directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of millet protein in humans on which nutrition recommendations can be built.

详细描述

Each subject will be part of 8 different experimental diets, and randomly assigned to one of the diets every time.

4 reference diet would be based on egg protein composition, 3 millet diets would have protein from cooked millet and 1 mixed meal would comprise of cooked millet and lentils.

Each experimental diet will be studied over 3 days: 2 adaptation and 1 study day. The 2 adaptation meals would be consumed at home. On the study day 3, following a 12-h overnight fast, subjects will come to the research unit at The Hospital for Sick Children, Toronto, ON for a period of 7.5 h and consume the diet as 9 hourly meals. The first 3 meals would be consumed at home.

For the duration of all experiments, subjects will consume a daily multivitamin supplement to ensure adequate vitamin intake.

Measurements:

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
18 Years 至 49 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male, age 18 - 49 yrs Healthy, with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes Stable Body Weight Not on any medications that could affect protein or amino acid metabolism e.g. steroids

排除标准

  • Unwillingness to participate or unable to tolerate the diet Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients)

研究组 & 干预措施

metabolic availability of lysine in millet

Experimental

Participants will be seen initially for pre-study assessment (2 hour). They will then be studied at 8 levels of lysine intake.

Subjects will visit SickKid's Clinical Research Center a total of 9 times, with each visit being at least one week before the next. All 9 visits must be made within 6 months. Each set of experiment consists of a 3 day period. During the first 2 days (Adaptation Days) you will be expected to consume 4 meals per day consisting of a protein liquid drink and protein free-cookies and/or cooked millet with or without lentils, which will all be provided by the investigators.

干预措施: Metabolic availability of lysine in millet (Dietary Supplement)

结局指标

主要结局

Metabolic availability of Lysine in millet

时间窗: 2 years

Apply the IAAO method to determine the Metabolic availability of Lysine in millet prepared by wet heat cooking method.

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

Glenda Courtney-Martin

Dietician

The Hospital for Sick Children

研究点 (2)

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