Background and aims: 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.
Conclusion: This study will determine whether the combination of TRE and Exercise induces superior benefits on hepatic fat, body composition and cardiometabolic risk factors, providing information about its efficacy and feasibility.
ClinicalTrials.gov ID: NCT05897073
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). Supported by the Spanish Ministry of Science and Innovation (FJC2020- 043385- I). Supported by the Spanish Ministry of Universities (FPU21/01161, FPU22/01631 and RD 289/2021).
