Sleep Restriction and Obesity
2022年1月18日 更新者：Virend Somers, MD, PhD、Mayo Clinic
Insufficient sleep may be one of the most common, and most preventable, obesity risk factors.
The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity.
The investigators hypothesize that sleep restriction will result in increased energy balance.
研究概览
详细说明
Numerous studies have reported that self-reported short sleep duration is associated with obesity and weight gain.
Insufficient sleep may be one of the most common, and most preventable, obesity risk factors.
Given that sleep restriction is largely voluntary and potentially correctable, understanding the mechanisms that link insufficient sleep to positive energy balance and the development of obesity, particularly visceral obesity, is crucial to clinical applications, public health policy, and informing future studies.
The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity.
The investigators will combine energy balance, biomarker, and imaging data with state-of-the art sleep monitoring to provide unambiguous data on the effects of sleep restriction on obesity.
Together, the investigators findings will help explain whether the reduced sleep duration in the general population may be contributing to the current epidemic of obesity, and suggest strategies to reduce this risk.
研究类型
介入性
注册 (实际的)
13
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
-
-
Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic in Rochester
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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
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 18-40 years
- BMI of 18.5-30 kg/m2
- Not a current smoker or tobacco user
- No chronic medical or psychiatric disorders
- On no prescription medications other than second generation antihistamines (cetirizine, fexofenadine, desloratadine, loratadine, etc), oral contraceptive pills, or intrauterine devices
- History of normal sleep patterns, defined as nocturnal sleep duration of 6.5-8 hours per night without regular daytime naps
Exclusion Criteria:
- The investigators will exclude subjects who have any medical or psychiatric disorders
- History of anxiety or depression
- Those taking any medications other than non-sedating antihistamines or oral contraceptives will be excluded
- Those found to have depression on a depression screening tool (BDI-II) will be excluded
- Current smokers will be excluded
- All female subjects will undergoing a screening pregnancy test and excluded if positive
- Subjects found to have significant sleep disorders will be excluded
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：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sleep restriction
|
14 days of sleep restriction, 4 hours of sleep per day.
|
|
无干预：Normal sleep
|
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 |
|---|---|---|
|
Change in caloric intake and hunger
大体时间：baseline to 21 days
|
Change in caloric intake and hunger, measured during acclimation, experimental and recovery timepoints.
|
baseline to 21 days
|
|
Change in energy expenditure
大体时间：baseline to 21 days
|
Change in energy expenditure, including activity energy expenditure, thermic effect of food (TEF), and basal metabolic rate (BMR), measured during acclimation, experimental and recovery timepoints..
|
baseline to 21 days
|
|
Change in fat tissue characteristics and body composition
大体时间：baseline to 21 days
|
Changes in fat tissue characteristics from serial fat biopsies, and in body composition from DEXA and CT imaging, measured during acclimation, experimental and recovery timepoints.
|
baseline to 21 days
|
|
Change in metabolic hormones
大体时间：baseline to 21 days
|
Change in metabolic hormones measured during acclimation, experimental and recovery timepoints.
|
baseline to 21 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in neurocognitive deficits
大体时间：baseline to 21 days
|
Change in neurocognitive function measured by battery, measured during acclimation, experimental and recovery timepoints..
|
baseline to 21 days
|
|
Change in blood pressure and autonomic function
大体时间：baseline to 21 days
|
Change in mean arterial blood pressure and autonomic function, measured during acclimation, experimental and recovery timepoints.
|
baseline to 21 days
|
|
Change in markers of inflammation and endothelial function
大体时间：baseline to 21 days
|
Change in markers of inflammation and endothelial function, measured during acclimation, experimental and recovery timepoints.
|
baseline to 21 days
|
|
Change in electrocardiographic characteristics
大体时间：baseline to 21 days
|
Change in electrocardiographic characteristics, measured during acclimation, experimental and recovery timepoints.
|
baseline to 21 days
|
|
Change in arterial stiffness
大体时间：baseline to 21 days
|
Change in arterial stiffness, measured during acclimation, experimental, and recovery timepoints.
|
baseline to 21 days
|
|
Change in cardiovascular reactivity
大体时间：baseline to 21 days
|
Change in cardiovascular reactivity, measured during acclimation, experimental, and recovery timepoints.
|
baseline to 21 days
|
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。
赞助
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
2012年7月1日
初级完成 (实际的)
2018年5月1日
研究完成 (实际的)
2018年5月1日
研究注册日期
首次提交
2012年4月17日
首先提交符合 QC 标准的
2012年4月17日
首次发布 (估计)
2012年4月19日
研究记录更新
最后更新发布 (实际的)
2022年1月21日
上次提交的符合 QC 标准的更新
2022年1月18日
最后验证
2022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.