BUSCADOR RECOLECTA

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., 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.

The optimal eating window for time-restricted eating (TRE) remains unclear, particularly its impact on visceral adipose tissue (VAT), which is associated with cardiometabolic morbidity and mortality. We investigated the effects of three TRE schedules (8 h windows in the early day, late day and participant-chosen times) combined with usual care (UC, based on education about the Mediterranean diet) versus UC alone over 12 weeks in adults with overweight or obesity. The primary outcome was VAT changes measured by magnetic resonance imaging. A total of 197 participants were randomized to UC (n = 49), early TRE (n = 49), late TRE (n = 52) or self-selected TRE (n = 47). No significant differences were found in VAT changes between early TRE (mean difference (MD): −4%; 95% confidence interval (CI), −12 to 4; P = 0.87), late TRE (MD: −6%; 95% CI, −13 to 2; P = 0.31) and self-selected TRE (MD: −3%; 95% CI, −11 to 5; P ≥ 0.99) compared with UC, nor among the TRE groups (all P ≥ 0.99). No serious adverse events occurred; five participants reported mild adverse events. Adherence was high (85–88%) across TRE groups. These findings suggest that adding TRE, irrespective of eating window timing, offers no additional benefit over a Mediterranean diet alone in reducing VAT. TRE appears to be a safe, well-tolerated and feasible dietary approach for adults with overweight or obesity. ClinicalTrials.gov registration: NCT05310721., This study (project reference PID2022.141506OB.I00) is funded by the MCIU/AEI /10.13039/501100011033 and by ERDF EU A Way of Making Europe to J.R.R.; Junta de Andalucía, Consejería de Transformación económica, Industria, Conocimiento y Universidades (A-CTS-516-UGR20) to J.R.R.; the University of Granada Plan Propio de Investigación-Excellence actions: Unit of Excellence on Exercise Nutrition and Health (UCEENS) to J.R.R.; the Consejo Superior de Deportes, Ministerio de Cultura y Deporte (project reference EXP_75091), Plan de Recuperación, Transformación y Resiliencia -Funded by the European Union NextGenerationEU to I.L.; the Government of Navarra, Departamento de Desarrollo Económico y Empresarial (0011-1365-2021-00070), Plan de Promoción de Grupos de Investigación de la Universidad Pública de Navarra to I.L.; Juan de la Cierva Formación (FJC2020-044453-I to J.M.A.A. and FJC2020-043385-I to A.C.-C.) funded by the Ministerio de Ciencia e Innovación and by the European Union NextGenerationEU/PRTR; Recualification of the Spanish University System 2021-2023 from the Spanish Ministry of Universities (RD 289/2021 to R. Cupeiro), funded by the European Union NextGenerationEU; Spanish Ministry of Universities (FPU 18/03357 to M.D.-M. and FPU21/01161 to A.C.J.); Spanish Ministry of Science, Innovation and Universities under Beatriz Galindo's 2022 fellowship program (ref: BG22/00075 to J.H.M.). In addition, funding was provided from the EXERNET Research Network on Exercise and Health (DEP2005-00046/ACTI; 09/UPB/19; 45/UPB/20; 27/UPB/21 to I.L. and J.R.R.). R.d.C. is funded through the Intramural Research Program of the National Institute on Aging. This work is part of a doctorate thesis conducted in the Official Doctoral Program in Biomedicine of the University of Granada, Spain.