Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance (DEV)
2013年1月18日 更新者：Washington University School of Medicine
VLDL-triglyceride Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance
This study is being conducted to learn more about the role of diet and exercise in regulating plasma triglyceride (fat) metabolism.
The investigators will examine the effect of acute (24 hour) changes in energy intake and expenditure on fat metabolism the following day.
研究概览
地位
完全的
条件
详细说明
Excess body fat and a sedentary lifestyle are associated with increased plasma triglyceride (TG) and apolipoprotein B-100 (apoB-100) concentrations, which are important risk factors for the development of cardiovascular disease.
Weight loss and endurance exercise improve plasma lipid and lipoprotein concentrations. However, the mechanisms responsible for this effect are largely unknown, and much uncertainty remains regarding the independent roles of dietary energy intake, exercise energy expenditure, and net energy balance in controlling plasma TG concentrations.
The main goal of this project, therefore, is to investigate the mechanisms by which acute alterations in energy balance, induced by diet and/or physical activity (endurance exercise), regulate very-low density lipoprotein (VLDL) metabolism.
Subjects will be asked to perform 3 separate trials. One of these will always be an "energy balance" trial that will act as the control trial for the other 2 trials they perform. Subjects will therefore be randomized to 2 different study arms.
研究类型
介入性
注册 (实际的)
12
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Missouri
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Saint Louis、Missouri、美国、63110
- Washington University in Saint Louis
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- overweight and obese men
- normal to mild hypertriglyceridemia
Exclusion Criteria:
- Smoking
- Any medical condition other than increased body weight (e.g. diabetes, heart disease, etc.).
- Use of drugs known to affect lipid metabolism (e.g. statins, etc.).
- Regular exercise training.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Positive energy balance
Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials
|
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
|
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实验性的：Energy balance with exercise
Comparison between an isocaloric diet without exercise and a hypercaloric diet with a sufficient amount of exercise performed to match the excess calories consumed resulting in both trials being in net energy balance.
|
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.
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实验性的：Negative energy balance
Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials
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Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.
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实验性的：Negative energy balance with exercise
Comparison between consuming an isocaloric diet without exercise and consuming the same amount of calories as in the isocaloric trial but with exercise performed resulting in net negative energy balance in the exercise trial.
|
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations
大体时间：After acute (24 hour) changes in energy intake and/or energy expenditure
|
After acute (24 hour) changes in energy intake and/or energy expenditure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 secretion rates
大体时间：After acute (24 hour) changes in energy intake and/or energy expenditure
|
After acute (24 hour) changes in energy intake and/or energy expenditure
|
|
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Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 clearance rates from plasma
大体时间：After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
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|
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Plasma glucose concentration and turnover rate
大体时间：After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
|
|
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Plasma insulin concentration
大体时间：After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
|
|
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Plasma free fatty acid concentration and turnover rate
大体时间：After acute (24 hour) changes in energy intake and/or energy expenditure
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After acute (24 hour) changes in energy intake and/or energy expenditure
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|
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Plasma glucose concentration
大体时间：During acute (24 hour) changes in energy intake and/or energy expenditure
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Measured hourly over the 24 h period.
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During acute (24 hour) changes in energy intake and/or energy expenditure
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Plasma insulin concentration
大体时间：During acute (24 hour) changes in energy intake and/or energy expenditure
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Measured hourly over the 24 h period.
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During acute (24 hour) changes in energy intake and/or energy expenditure
|
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Plasma free fatty acid concentration
大体时间：During acute (24 hour) changes in energy intake and/or energy expenditure
|
Measured hourly over the 24 h period.
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During acute (24 hour) changes in energy intake and/or energy expenditure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年4月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2009年1月26日
首先提交符合 QC 标准的
2009年1月26日
首次发布 (估计)
2009年1月28日
研究记录更新
最后更新发布 (估计)
2013年1月21日
上次提交的符合 QC 标准的更新
2013年1月18日
最后验证
2013年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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