Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled trial.

Autor:	Camacho-Cardenosa A; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain ruizj@ugr.es acamachocardenos@ugr.es., Clavero-Jimeno A; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain., Martin-Olmedo JJ; Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology, Biomedical Research Centre, University of Granada, Granada, Spain., Amaro-Gahete F; Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.; Department of Physiology, Faculty of Medicine, University of Granada, Granada, Spain.; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain., Cupeiro R; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.; LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science (INEF), Universidad Politécnica de Madrid, Madrid, Spain., Cejudo MTG; Servicio de Análisis Clínicos, Hospital Universitario San Cecilio, Granada, Spain., García Pérez PV; Servicio de Radiodiagnóstico, Hospital Universitario San Cecilio, Granada, Spain., Hernández-Martínez C; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain., Sevilla-Lorente R; Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology, Biomedical Research Centre, University of Granada, Granada, Spain., De-la-O A; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain., López-Vázquez A; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain., Molina-Fernandez M; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain., Carneiro-Barrera A; Department of Psychology, Universidad Loyola Andalucía, Sevilla, Spain., Garcia F; Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.; Servicio de Microbiología, Hospital Universitario San Cecilio, Granada, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERinfecc), Instituto de Salud Carlos III, Madrid, Spain., Rodríguez-Nogales A; Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.; Department of Pharmacology, School of Pharmacy, University of Granada, Granada, Spain., Gálvez Peralta JJ; Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.; Department of Pharmacology, Center for Biomedical Research, Granada, Spain., Cabeza R; Department of Electrical, Electronic and Communications Engineering, Public University of Navarre, Pamplona, Spain., Martín-Rodríguez JL; Servicio de Radiodiagnóstico, Hospital Universitario San Cecilio, Granada, Spain., Muñoz-Garach A; Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain.; Endocrinology and Nutrition Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain., Muñoz-Torres M; Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.; Endocrinology and Nutrition Unit, Hospital Universitario San Cecilio, Granada, Spain.; Department of Medicine, Faculty of Medicine, University of Granada, Granada, Spain.; Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain., Labayen I; Navarre Institute of Health Research, Pamplona, Spain.; Institute for Sustainability & Food Chain Innovation, Department of Health Sciences, Public University of Navarre, Pamplona, Spain., Ruiz JR; Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain ruizj@ugr.es acamachocardenos@ugr.es.; Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.; Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jan 24; Vol. 14 (1), pp. e078472. Date of Electronic Publication: 2024 Jan 24.
DOI:	10.1136/bmjopen-2023-078472
Abstrakt:	Introduction: 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. Methods and Analysis: 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. Ethics and Dissemination: 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. Trial Registration Number: NCT05897073. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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