此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Effect of Early Eating on Body Composition

2020年12月16日 更新者:Western University, Canada

Effect of Early vs. Late Eating on Body Composition in Young Adults

To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here. The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults. The eating window also began later in the morning at 1000h and finished at 1800h. There also was no restriction on participants consuming caffeine during the fasting window. The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition. The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8. The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window. Furthermore, none of the studies mentioned above examined eTRE against lTRE directly. We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.

研究概览

详细说明

Purpose The purpose of the study is to determine the effects of early and late time restricted eating on body composition in overweight and obese young adults. It is hypothesized that early time restricted eating will provide a more desirable effect (lower fat mass) on body composition for the participants.

Sample The sample will include 30 overweight/obese young adults, male and female, ranging in age from 18-30 that volunteer to participate in the study. This sample size is justified assuming a standard deviation of 1.5 based on previous studies and using a power of 80% with the statistical significance of 0.05 the resulting n would be 2(1.5)^2*(0.84+1.96)^2/5=7 (Kadam, P., & Bhalerao, S. (2010). Sample size calculation. International journal of Ayurveda research, 1(1), 55). To account for dropouts/non-interest in participation, 10 participants will be recruited for each group. All individuals must give written informed consent in order to participate in the study. Exclusion criteria include self-reported: diabetes, smoking, CVD, pregnancy, weight loss medication, physical activity level greater than low/sedentary (7500 steps daily), unstable weight (>4kg loss/gain) for 3 months prior to study commencement.

Procedure Inclusion/exclusion criteria will be explicitly stated throughout the recruitment process. Potential participants will be recruited through mass email recruitment via Western email services, presenting one-slide information sessions at the beginning of lectures and posting flyers around campus. Participants will then be in direct contact with Reed Zehr to set up a meeting to gain information of the study. After the information meeting the individuals will be given up to 3 days to determine if they want to participate and give their informed consent. See attached form in the consent section of the ethics application.

Measurement: All participants will be required to have their Body Composition measured using non-invasive densitometry (BodPod). The procedure poses no risk to the participant and takes approximately 5 minutes to complete. This procedure will take place initially one week prior to study commencement and then every 4 weeks after study commencement until the 12 weeks of the study duration are complete. This results in a total of 4 measurements. Upper body strength measurements will be recorded one week prior to commencement of the study and once again after study completion using a maximal bench press test. Lower body strength measurements will be recorded one week prior to commencement of the study and once again after study completion using a maximal leg press test. Completion of a health-related quality of life questionnaire one week prior to commencement of the study and once again after study completion is also required.

研究类型

介入性

注册 (预期的)

30

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

    • Ontario
      • London、Ontario、加拿大、N6A3K7
        • Exercise Nutrition Laboratory, Western University

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 30年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • sedentary- lightly physically active (<7,500 steps daily)
  • BMI > 25
  • 18-30 yo.

Exclusion Criteria:

  • Have diabetes (self-reported)
  • Have history of smoking (self-reported)
  • Have history of cardiovascular disease (self-reported)
  • Have BMI of <24.9
  • Are pregnant or become pregnant during the study (self-reported)
  • Take medication for weight loss (self-reported)
  • Physical activity level > 7500 steps/day
  • Unstable weight for 3 months prior to commencement of study (>4kg weight loss/gain)
  • Employed in a shift work position

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:治疗
  • 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
实验性的:eTRE
participants allocated to this group will be required to eat only between 0800h and 1600h.
early vs late time of day restriction
有源比较器:lTRE
participants allocated to this group will be required to eat only between 1200h and 2000h
early vs late time of day restriction

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
Body Composition
大体时间:<5 mins
fat mass vs. fat-free mass via BodPod
<5 mins

次要结果测量

结果测量
措施说明
大体时间
upper body strength test
大体时间:<10 mins
1 rep maximal progressive loading bench press test
<10 mins
lower body strength test
大体时间:<10 mins
1 rep maximal progressive loading leg press test
<10 mins
health related quality of life questionnaire
大体时间:<10 mins
subjective feelings of overall health per participant
<10 mins

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。

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 (预期的)

2021年1月1日

初级完成 (预期的)

2021年4月1日

研究完成 (预期的)

2021年6月1日

研究注册日期

首次提交

2020年12月16日

首先提交符合 QC 标准的

2020年12月16日

首次发布 (实际的)

2020年12月22日

研究记录更新

最后更新发布 (实际的)

2020年12月22日

上次提交的符合 QC 标准的更新

2020年12月16日

最后验证

2020年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 117951

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅