Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine (LEUCI)
Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Murcia、西班牙、30107
- Catholic University of Murcia
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects of both sexes with age between 55-70 years.
- Body mass index less than 35.
- Subjects who have given written informed consent to participate in the study.
Exclusion Criteria:
- Consumption during the 6 months prior to the study of functional food enriched with leucine or nutritional supplement based on protein concentrate or that presents in its chemical composition leucine.
- Presence of absolute or relative contraindications ruled by the American College of Sports Medicine (ACSM, 1995), during the performance of stress tests.
- Presence of chronic diseases that prevent the performance of a physical exercise program or an exercise test (disabling arthropathies, moderate / severe chronic lung diseases, ischemic heart disease under treatment, arrhythmias, etc).
- Abuse in the ingestion of alcohol.
- Present hypersensitivity or intolerance to any of the components of the products under study.
- Inability to understand informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Experimental group 1 (TS + placebo)
Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
实验性的：Experimental group 2 (TS + leucine)
Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
实验性的：Experimental group 3 (HRC + placebo)
Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
实验性的：Experimental group 4 (HRC + leucine)
Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
实验性的：Experimental group 5 (no physical exercise + leucine)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of milk enriched with leucine. |
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training |
|
无干预：Control (no physical exercise + placebo)
The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Muscle mass
大体时间：Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
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Total fat mass
大体时间：Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
|
Change of this measurement at 3 months.
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Total fat free mass
大体时间：Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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Fat free mass on upper limb
大体时间：Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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Upper limb fat mass
大体时间：Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
|
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Fat-free mass in the lower limb
大体时间：Change of this measurement at 3 months.
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Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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Lower limb fat mass
大体时间：Change of this measurement at 3 months.
|
Dual X-ray absorptiometry (DEXA)
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Change of this measurement at 3 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Elbow extension
大体时间：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
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Upper limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
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Elbow flexion
大体时间：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
Upper limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
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Knee extension
大体时间：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
Lower limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
|
Knee flexion
大体时间：This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
Lower limb isokinetic dynamometry.
The angular velocities used were 60 ° · s-1 and 270 ° · s-1.
The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
|
This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
|
|
Blood samples: Glycid metabolism and lipid metabolism.
大体时间：Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides.
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Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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Liver safety variables
大体时间：Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver.
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Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UCAMCFE-00013
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