AI Article Synopsis
- The study aims to evaluate the impact of a 12-week time-restricted eating (TRE) program and supervised exercise on liver fat and overall health in adults with obesity, comparing it to usual care and each intervention separately.
- A total of 184 adults will be randomly assigned to one of four groups: usual care, TRE alone, supervised exercise alone, or a combination of both TRE and exercise, with ongoing nutritional counseling provided.
- The primary goal is to measure changes in hepatic fat, while secondary outcomes will assess various cardiometabolic health indicators, and the study has received ethical approval for its execution.
Article Abstract
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.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10824004 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2023-078472 | DOI Listing |
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