Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain
Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.
BMJ Open. 2024 Jan 24;14(1):e078472. doi: 10.1136/bmjopen-2023-078472.
Metabolic dysfunction-associated steatotic liver disease is a major public health problem considering its high prevalence and its strong association with extrahepatic diseases. Implementing strategies based on an intermittent fasting approach and supervised exercise may mitigate the risks. This study aims to investigate the effects of a 12-week time-restricted eating (TRE) intervention combined with a supervised exercise intervention, compared with TRE or supervised exercise alone and with a usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity.
An anticipated 184 adults with obesity (50% women) will be recruited from Granada (south of Spain) for this parallel-group, randomised controlled trial (TEMPUS). Participants will be randomly designated to usual care, TRE alone, supervised exercise alone or TRE combined with supervised exercise, using a parallel design with a 1:1:1:1 allocation ratio. The TRE and TRE combined with supervised exercise groups will select an 8-hour eating window before the intervention and will maintain it over the intervention. The exercise alone and TRE combined with exercise groups will perform 24 sessions (2 sessions per week+walking intervention) of supervised exercise combining resistance and aerobic high-intensity interval training. All participants will receive nutritional counselling throughout the intervention. The primary outcome is change from baseline to 12 weeks in hepatic fat; secondary outcomes include measures of cardiometabolic health.
This study was approved by Granada Provincial Research Ethics Committee (CEI Granada-0365-N-23). All participants will be asked to provide written informed consent. The findings will be disseminated in scientific journals and at international scientific conferences.
NCT05897073.
考虑到其高患病率及其与肝外疾病的强烈关联，代谢功能障碍相关的脂肪性肝病是一个主要的公共卫生问题。实施基于限时进食法和监督锻炼的策略可能会降低风险。本研究旨在调查限时进食干预联合监督锻炼干预与限时进食或监督锻炼单独干预以及常规护理对照组相比，对肥胖成年人的肝脂肪（主要结果）和心脏代谢健康（次要结果）的影响。
这项平行组随机对照试验（TEMPUS）预计将从西班牙南部的格拉纳达招募 184 名肥胖成年人（50%为女性）。参与者将被随机分配到常规护理、单独限时进食、单独监督锻炼或限时进食联合监督锻炼组，采用 1:1:1:1 的平行设计分配比例。限时进食和限时进食联合监督锻炼组将在干预前选择 8 小时的进食窗口，并在干预期间保持不变。单独监督锻炼和限时进食联合锻炼组将进行 24 次监督锻炼（每周 2 次+步行干预），结合阻力和有氧高强度间歇训练。所有参与者将在整个干预过程中接受营养咨询。主要结果是从基线到 12 周肝脂肪的变化；次要结果包括心脏代谢健康的测量。
这项研究已获得格拉纳达省研究伦理委员会（CEI Granada-0365-N-23）的批准。所有参与者都将被要求提供书面知情同意书。研究结果将在科学期刊和国际科学会议上发表。
NCT05897073。
