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

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dc.contributor.authorCamacho-Cardenosa, Alba
dc.contributor.authorClavero-Jimeno, Antonio
dc.contributor.authorMartín-Olmedo, Juan J.
dc.contributor.authorAmaro Gahete, Francisco J.
dc.contributor.authorCupeiro, Rocío
dc.contributor.authorGonzález Cejudo, María Trinidad
dc.contributor.authorGarcía Pérez, Patricia Virginia
dc.contributor.authorHernández-Martínez, Carlos
dc.contributor.authorSevilla-Lorente, Raquel
dc.contributor.authorO, Alejandro de la
dc.contributor.authorLópez-Vázquez, Alejandro
dc.contributor.authorMolina-Fernández, Marcos
dc.contributor.authorCarneiro-Barrera, Almudena
dc.contributor.authorGarcía, Federico
dc.contributor.authorRodríguez-Nogales, Alba
dc.contributor.authorGálvez Peralta, Julio Juan
dc.contributor.authorCabeza Laguna, Rafael
dc.contributor.authorMartín-Rodríguez, José L.
dc.contributor.authorMuñoz-Garach, Araceli
dc.contributor.authorMuñoz Torres, Manuel
dc.contributor.authorLabayen Goñi, Idoia
dc.contributor.authorRuiz, Jonatan R.
dc.contributor.departmentCiencias de la Saludes_ES
dc.contributor.departmentOsasun Zientziakeu
dc.contributor.departmentIngeniería Eléctrica, Electrónica y de Comunicaciónes_ES
dc.contributor.departmentIngeniaritza Elektrikoa, Elektronikoaren eta Telekomunikazio Ingeniaritzareneu
dc.contributor.departmentInstitute on Innovation and Sustainable Development in Food Chain - ISFOODen
dc.date.accessioned2024-05-22T19:00:22Z
dc.date.available2024-05-22T19:00:22Z
dc.date.issued2024
dc.date.updated2024-05-22T18:03:45Z
dc.description.abstractIntroduction. 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 análisis. 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.en
dc.description.sponsorshipThis study is funded by the Spanish Ministry of Science, Innovation and Universities (PID2022-141506OB-I00) and the European Regional Development Funds (ERDF), Agencia Estatal de Investigación; the University of Granada Plan Propio de Investigación-Excellence actions: Unit of Excellence on Exercise Nutrition and Health (UCEENS). AC-C is supported by the Spanish Ministry of Science and Innovation (FJC2020-043385-I). AC-J is supported by the Spanish Ministry of Universities (FPU21/01161). JJM-O is supported by the Spanish Ministry of Universities (FPU22/01631)RC is supported by a grant for the Requalification of the Spanish University System 2021–2023 from the Spanish Ministry of Universities (RD 289/2021), funded by the European Union-Next Generation EU.en
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dc.format.mimetypeapplication/zipen
dc.identifier.citationCamacho-Cardenosa, A., Clavero-Jimeno, A., Martin-Olmedo, J. J., Amaro-Gahete, F., Cupeiro, R., Cejudo, M. T. G., García Pérez, P. V., Hernández-Martínez, C., Sevilla-Lorente, R., De-la-O, A., López-Vázquez, A., Molina-Fernandez, M., Carneiro-Barrera, A., Garcia, F., Rodríguez-Nogales, A., Gálvez Peralta, J. J., Cabeza, R., Martín-Rodríguez, J. L., Muñoz-Garach, A., Muñoz-Torres, M., Labayen, I., Ruiz, J. R. (2024) Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: Protocol for the TEMPUS randomised controlled trial. BMJ Open, 14(1), 1-13. https://doi.org/10.1136/bmjopen-2023-078472.en
dc.identifier.doi10.1136/bmjopen-2023-078472
dc.identifier.issn2044-6055
dc.identifier.urihttps://academica-e.unavarra.es/handle/2454/48186
dc.language.isoengen
dc.publisherBMJ Publishing Groupen
dc.relation.ispartofBMJ Open 2024, 14(1), e078472.en
dc.relation.projectIDinfo:eu-repo/grantAgreement/AEI/Plan Estatal de Investigación Científica y Técnica y de Innovación 2021-2023/PID2022-141506OB-I00/ES/
dc.relation.publisherversionhttps://doi.org/10.1136/bmjopen-2023-078472
dc.rights© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY.en
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectCardiovascular imagingen
dc.subjectGeneral endocrinologyen
dc.subjectObesityen
dc.titleTime-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled trialen
dc.typeinfo:eu-repo/semantics/article
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dspace.entity.typePublication
relation.isAuthorOfPublication42fe20f8-5341-4c0e-8686-333ce816adfd
relation.isAuthorOfPublicationb36e2b1d-3088-4089-806e-fd3040e9583a
relation.isAuthorOfPublication.latestForDiscovery42fe20f8-5341-4c0e-8686-333ce816adfd

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