The Effect of Time-Restricted Eating in 24-hour Metabolic Homeostasis and Diurnal Rhythm (Rhythm)
2026年9月9日 更新者：Maria Chondronikola、Cambridge University Hospitals NHS Foundation Trust
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no food intake during the rest of the day.
In animals, TRE improves metabolic function without caloric restriction.
However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue.
This study is a randomized controlled trial in people with obesity and prediabetes/insulin resistance.
The overall goal of the study is to determine the effect of 9 h TRE for 12 weeks on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): The goal of this study is to answer the following questions: 1) 24-hour metabolic homeostasis 2) 24h diurnal rhythm and appetite regulation.
研究概览
研究类型
介入性
注册 (估计的)
26
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。
学习联系方式
- 姓名：Maria Chondronikola
- 电话号码：+4401223746784
- 邮箱：mc2425@medschl.cam.ac.uk
学习地点
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Cambridge、英国、CB2 0QQ
- Cambridge Clinical Research Centre
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接触：
- Krishna Chatterjee
- 电话号码：+4401223 254800
- 邮箱：tdw30@medschl.cam.ac.uk
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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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- willing and able to give informed consent for participation in the study
- aged 35-75 years
- men and women
- body mass index 27-45 kg/m2
- fasting plasma glucose 5.6-6.9 mmol/L, or 2h OGTT plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol, homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73
- self-reported habitual eating period ≥ 13 h per day
Exclusion Criteria:
- shift worker
- fasting >12 h/day more than once a week
- vegan
- > once a week no food intake after ~1800 h
- habitually waking up before ~0400 h and sleeping before ~2100 h
- unstable weight (>5% change the last 2 months)
- type 1 or 2 diabetes
- sleep disorder (individuals with well-controlled sleep apnoea)
- eating disorder
- cancer in last 5 years
- conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study)
- use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.)
- smoking and illegal drug use
- pregnant or lactating
- gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)
- unable to grant voluntary informed consent or comply with the study instructions
- individuals with electromedical devices
- prisoners
- alcohol abuse
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：并行分配
- 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：TRE Group
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
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分配到 TRE 组的参与者必须在 12 周的 9 小时窗口内消耗所有日常膳食和零食。
Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention.
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有源比较器：Control Group
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
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将向参与者提供营养教育和咨询，以遵循与现有慢性病预防指南一致的饮食。
分配到对照组的参与者必须在 12 周的 14 小时时间内吃完所有每日正餐和零食。
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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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Blood glucose concentration using a YSI analyzer
大体时间：3 months (pre-post intervention)
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Changes in 24-h area under the curve for blood glucose concentration will be assessed during a 24h metabolic test day.
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3 months (pre-post intervention)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum insulin concentration using a chemiluminescent assay
大体时间：3 months (pre-post intervention)
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Changes in s24-h area under the curve for serum insulin concentration will be assessed during a 24h metabolic test day.
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3 months (pre-post intervention)
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Serum C-peptide concentration using an ELISA assay
大体时间：3 months (pre-post intervention)
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Changes in 24-h area under the curve for serum C-peptide concentration will be assessed during a 24h metabolic test day.
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3 months (pre-post intervention)
|
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Plasma FFA concentration using a colorimetric assay
大体时间：3 months (pre-post intervention)
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Changes in plasma 24-h area under the curve for plasma FFA concentration will be assessed during a 24h metabolic test day.
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3 months (pre-post intervention)
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Plasma TG concentration using a colorimetric assay
大体时间：3 months (pre-post intervention)
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Changes in 24-h area under the curve for plasma TG concentration will be assessed during a 24h metabolic test day.
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3 months (pre-post intervention)
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Serum GLP1 concentration using a V-plex assay
大体时间：3 months (pre-post intervention)
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Changes in 24-h area under the curve for serum GLP1 concentration will be assessed during a 24h metabolic test day.
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3 months (pre-post intervention)
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Serum GIP concentration using a V-plex assay
大体时间：3 months (pre-post intervention)
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Changes in 24-h area under the curve for serum GIP concentration will be assessed during a 24h metabolic test day.
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3 months (pre-post intervention)
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Hunger sensation using a standardised questionnaire (visual analog scale)
大体时间：3 months (pre-post intervention)
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Changes in subjective evaluations hunger during a 24h metabolic test day using standardised visual analog scales of hunger satiety
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3 months (pre-post intervention)
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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 (估计的)
2026年9月15日
初级完成 (估计的)
2031年3月1日
研究完成 (估计的)
2031年5月30日
研究注册日期
首次提交
2026年7月7日
首先提交符合 QC 标准的
2026年9月9日
首次发布 (实际的)
2026年9月15日
研究记录更新
最后更新发布 (实际的)
2026年9月15日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9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.