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10 小时限时进食对 24 小时轮班工作的职业消防员患心血管疾病风险的可行性和影响的随机对照试验方案:健康英雄研究。

Protocol for a randomised controlled trial on the feasibility and effects of 10-hour time-restricted eating on cardiometabolic disease risk among career firefighters doing 24-hour shift work: the Healthy Heroes Study.

机构信息

Regulatory Biology Laboratory, Salk Institute for Biological Studies, La Jolla, California, USA.

Division of Cardiovascular Diseases, Department of Medicine, University of California San Diego School of Medicine, La Jolla, California, USA.

出版信息

BMJ Open. 2021 Jun 16;11(6):e045537. doi: 10.1136/bmjopen-2020-045537.

Abstract

INTRODUCTION

Career firefighters experience chronic circadian rhythm disruption, increasing their risk of cardiometabolic disease. The recent discovery that eating patterns regulate circadian rhythmicity in metabolic organs has raised the hypothesis that maintaining a consistent daily cycle of eating and fasting can support circadian rhythms and reduce disease risks. Preclinical animal studies and preliminary clinical trials have shown promising effects of time-restricted eating (TRE) to reduce disease risk without compromising physical performance. However, there is a lack of research on TRE in shift workers including firefighters. This study aims to investigate the feasibility and efficacy of 10-hour TRE on health parameters that contribute to cardiometabolic disease risks among career firefighters who work on a 24-hour shift schedule.

METHODS AND ANALYSES

The Healthy Heroes Study is a randomised controlled parallel open-label clinical trial with 150 firefighters over 1 year. Firefighters are randomised with a 1:1 ratio to either the control or intervention group. The control group receives Mediterranean diet nutritional counselling (standard of care, 'SOC'). The intervention group receives the same SOC and a self-selected 10-hour TRE window. After the 2-week baseline, participants enter a 3-month monitored intervention, followed by a 9-month self-guided period with follow-up assessments. The impact of TRE on blood glucose, body weight, body composition, biomarkers (neuroendocrine, inflammatory and metabolic), sleep and mood is evaluated. These assessments occur at baseline, at the end of intervention and at 6, 9 and 12-month follow-ups. Temporal calorie intake is monitored with the smartphone application myCircadianClock throughout the study. Continuous glucose monitors, wrist-worn actigraphy device and questionnaires are used to monitor glucose levels, activity, sleep and light exposure.

ETHICS AND DISSEMINATION

The study was approved by the Institutional Review Boards of the University of California San Diego and the Salk Institute for Biological Studies. Results will be disseminated through peer-reviewed manuscripts, reports and presentations.

TRIAL REGISTRATION NUMBER

NCT03533023; Pre result.

摘要

简介

职业消防员经历慢性昼夜节律紊乱,增加了患心脏代谢疾病的风险。最近的发现表明,饮食模式调节代谢器官的昼夜节律性,这就提出了一个假设,即保持进食和禁食的一致日常周期可以支持昼夜节律并降低疾病风险。临床前动物研究和初步临床试验表明,限时进食(TRE)在不影响身体表现的情况下,具有降低疾病风险的有希望的效果。然而,对于包括消防员在内的轮班工人的 TRE 研究还很缺乏。这项研究旨在调查 10 小时 TRE 对职业消防员健康参数的可行性和效果,这些参数会增加他们患心脏代谢疾病的风险,这些消防员的工作时间是 24 小时轮班制。

方法和分析

健康英雄研究是一项为期 1 年的随机对照平行开放标签临床试验,涉及 150 名消防员。消防员以 1:1 的比例随机分为对照组或干预组。对照组接受地中海饮食营养咨询(标准护理,“SOC”)。干预组接受相同的 SOC 和自我选择的 10 小时 TRE 窗口。在 2 周的基线后,参与者进入为期 3 个月的监测干预,然后是为期 9 个月的自我指导期,并进行随访评估。评估 TRE 对血糖、体重、身体成分、生物标志物(神经内分泌、炎症和代谢)、睡眠和情绪的影响。这些评估在基线、干预结束时以及 6、9 和 12 个月的随访时进行。通过智能手机应用程序 myCircadianClock 在整个研究过程中监测时间卡路里摄入量。连续血糖监测仪、腕戴活动记录仪和问卷用于监测血糖水平、活动、睡眠和光照。

伦理和传播

该研究得到了加利福尼亚大学圣地亚哥分校和索尔克生物研究所的机构审查委员会的批准。结果将通过同行评议的论文、报告和演讲进行传播。

试验注册号

NCT03533023;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eb95/8211050/286834af95d8/bmjopen-2020-045537f01.jpg

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