Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled trial
Fecha
2024Autor
Versión
Acceso abierto / Sarbide irekia
Tipo
Artículo / Artikulua
Versión
Versión publicada / Argitaratu den bertsioa
Identificador del proyecto
Impacto
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10.1136/bmjopen-2023-078472
Resumen
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) intervent ...
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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 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. [--]
Materias
Cardiovascular imaging,
General endocrinology,
Obesity
Editor
BMJ Publishing Group
Publicado en
BMJ Open 2024, 14(1), e078472.
Departamento
Universidad Pública de Navarra. Departamento de Ciencias de la Salud /
Nafarroako Unibertsitate Publikoa. Osasun Zientziak Saila /
Universidad Pública de Navarra. Departamento de Ingeniería Eléctrica, Electrónica y de Comunicación /
Nafarroako Unibertsitate Publikoa. Ingeniaritza Elektrikoa, Elektronikoa eta Telekomunikazio Ingeniaritza Saila /
Universidad Pública de Navarra/Nafarroako Unibertsitate Publikoa. Institute on Innovation and Sustainable Development in Food Chain - ISFOOD
Versión del editor
Entidades Financiadoras
This 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.