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

doi:10.1136/bmjopen-2023-078472

. 2024 Jan 24;14(1):e078472.

doi: 10.1136/bmjopen-2023-078472.

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

Alba Camacho-Cardenosa¹, Antonio Clavero-Jimeno², Juan J Martin-Olmedo³, Francisco Amaro-Gahete^{4

5

6}, Rocío Cupeiro^{2

7}, María Trinidad González Cejudo⁸, Patricia Virginia García Pérez⁹, Carlos Hernández-Martínez², Raquel Sevilla-Lorente³, Alejandro De-la-O^{2

6}, Alejandro López-Vázquez², Marcos Molina-Fernandez², Almudena Carneiro-Barrera¹⁰, Federico Garcia^{4

11

12}, Alba Rodríguez-Nogales^{4

13

14}, Julio Juan Gálvez Peralta^{4

13

15}, Rafael Cabeza¹⁶, José L Martín-Rodríguez⁹, Araceli Muñoz-Garach^{4

6

17}, Manuel Muñoz-Torres^{4

18

19

20}, Idoia Labayen^{21

22}, Jonatan R Ruiz^{1

4

6}

Affiliations

¹ Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain ruizj@ugr.es acamachocardenos@ugr.es.
² Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.
³ Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology, Biomedical Research Centre, University of Granada, Granada, Spain.
⁴ Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.
⁵ Department of Physiology, Faculty of Medicine, University of Granada, Granada, Spain.
⁶ Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain.
⁷ LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science (INEF), Universidad Politécnica de Madrid, Madrid, Spain.
⁸ Servicio de Análisis Clínicos, Hospital Universitario San Cecilio, Granada, Spain.
⁹ Servicio de Radiodiagnóstico, Hospital Universitario San Cecilio, Granada, Spain.
¹⁰ Department of Psychology, Universidad Loyola Andalucía, Sevilla, Spain.
¹¹ Servicio de Microbiología, Hospital Universitario San Cecilio, Granada, Spain.
¹² Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERinfecc), Instituto de Salud Carlos III, Madrid, Spain.
¹³ Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
¹⁴ Department of Pharmacology, School of Pharmacy, University of Granada, Granada, Spain.
¹⁵ Department of Pharmacology, Center for Biomedical Research, Granada, Spain.
¹⁶ Department of Electrical, Electronic and Communications Engineering, Public University of Navarre, Pamplona, Spain.
¹⁷ Endocrinology and Nutrition Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.
¹⁸ Endocrinology and Nutrition Unit, Hospital Universitario San Cecilio, Granada, Spain.
¹⁹ Department of Medicine, Faculty of Medicine, University of Granada, Granada, Spain.
²⁰ Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain.
²¹ Navarre Institute of Health Research, Pamplona, Spain.
²² Institute for Sustainability & Food Chain Innovation, Department of Health Sciences, Public University of Navarre, Pamplona, Spain.

PMID: 38267239
PMCID: PMC10824004
DOI: 10.1136/bmjopen-2023-078472

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

Alba Camacho-Cardenosa et al. BMJ Open. 2024.

. 2024 Jan 24;14(1):e078472.

doi: 10.1136/bmjopen-2023-078472.

Authors

Affiliations

¹ Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain ruizj@ugr.es acamachocardenos@ugr.es.
² Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Granada, Spain.
³ Department of Physiology, Faculty of Pharmacy, Institute of Nutrition and Food Technology, Biomedical Research Centre, University of Granada, Granada, Spain.
⁴ Instituto de Investigación Biosanitaria, Ibs, University of Granada, Granada, Spain.
⁵ Department of Physiology, Faculty of Medicine, University of Granada, Granada, Spain.
⁶ Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain.
⁷ LFE Research Group, Department of Health and Human Performance, Faculty of Physical Activity and Sport Science (INEF), Universidad Politécnica de Madrid, Madrid, Spain.
⁸ Servicio de Análisis Clínicos, Hospital Universitario San Cecilio, Granada, Spain.
⁹ Servicio de Radiodiagnóstico, Hospital Universitario San Cecilio, Granada, Spain.
¹⁰ Department of Psychology, Universidad Loyola Andalucía, Sevilla, Spain.
¹¹ Servicio de Microbiología, Hospital Universitario San Cecilio, Granada, Spain.
¹² Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERinfecc), Instituto de Salud Carlos III, Madrid, Spain.
¹³ Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
¹⁴ Department of Pharmacology, School of Pharmacy, University of Granada, Granada, Spain.
¹⁵ Department of Pharmacology, Center for Biomedical Research, Granada, Spain.
¹⁶ Department of Electrical, Electronic and Communications Engineering, Public University of Navarre, Pamplona, Spain.
¹⁷ Endocrinology and Nutrition Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.
¹⁸ Endocrinology and Nutrition Unit, Hospital Universitario San Cecilio, Granada, Spain.
¹⁹ Department of Medicine, Faculty of Medicine, University of Granada, Granada, Spain.
²⁰ Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERfes), Instituto de Salud Carlos III, Madrid, Spain.
²¹ Navarre Institute of Health Research, Pamplona, Spain.
²² Institute for Sustainability & Food Chain Innovation, Department of Health Sciences, Public University of Navarre, Pamplona, Spain.

PMID: 38267239
PMCID: PMC10824004
DOI: 10.1136/bmjopen-2023-078472

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.

Keywords: Cardiovascular imaging; General endocrinology; Obesity.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
TEMPUS project design. TRE, time-restricted eating; CVD, cardiovascular diseases.

**Figure 2**
Supervised exercise periodisation of the TEMPUS project. *Week of familiarisation. HIIT, high-intensity interval training; HRR, heart rate reserve; RPE, rate of perceived exertion; RT, resistance training. AET, aerobic endurance training.

See this image and copyright information in PMC

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References

1. WHO Regional office for Europe . WHO European Regional Obesity Report 2022. 2022: 1–220.
1. Tan CY, Vidal-Puig A. Adipose tissue expandability: the metabolic problems of obesity may arise from the inability to become more obese. Biochem Soc Trans 2008;36(Pt 5):935–40. 10.1042/BST0360935 - DOI - PubMed
1. Mantovani A, Scorletti E, Mosca A, et al. . Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism 2020;111S:154170. 10.1016/j.metabol.2020.154170 - DOI - PubMed
1. Lazarus JV, Newsome PN, Francque SM, et al. . A multi-society Delphi consensus statement on new fatty liver disease nomenclature. Hepatology November 20, 2023. 10.1097/HEP.0000000000000696 Available: http://www.journal-of-hepatology.eu/article/S016882782300418X/fulltext - DOI - PubMed
1. Armstrong MJ, Adams LA, Canbay A, et al. . Extrahepatic complications of nonalcoholic fatty liver disease. Hepatology [Internet] 2014;59:1174–97. 10.1002/hep.26717 - DOI - PubMed

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[1] WHO Regional office for Europe . WHO European Regional Obesity Report 2022. 2022: 1–220.

[2] WHO Regional office for Europe . WHO European Regional Obesity Report 2022. 2022: 1–220.

[3] Tan CY, Vidal-Puig A. Adipose tissue expandability: the metabolic problems of obesity may arise from the inability to become more obese. Biochem Soc Trans 2008;36(Pt 5):935–40. 10.1042/BST0360935 - DOI - PubMed

[4] Tan CY, Vidal-Puig A. Adipose tissue expandability: the metabolic problems of obesity may arise from the inability to become more obese. Biochem Soc Trans 2008;36(Pt 5):935–40. 10.1042/BST0360935 - DOI - PubMed

[5] Mantovani A, Scorletti E, Mosca A, et al. . Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism 2020;111S:154170. 10.1016/j.metabol.2020.154170 - DOI - PubMed

[6] Mantovani A, Scorletti E, Mosca A, et al. . Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism 2020;111S:154170. 10.1016/j.metabol.2020.154170 - DOI - PubMed

[7] Lazarus JV, Newsome PN, Francque SM, et al. . A multi-society Delphi consensus statement on new fatty liver disease nomenclature. Hepatology November 20, 2023. 10.1097/HEP.0000000000000696 Available: http://www.journal-of-hepatology.eu/article/S016882782300418X/fulltext - DOI - PubMed

[8] Lazarus JV, Newsome PN, Francque SM, et al. . A multi-society Delphi consensus statement on new fatty liver disease nomenclature. Hepatology November 20, 2023. 10.1097/HEP.0000000000000696 Available: http://www.journal-of-hepatology.eu/article/S016882782300418X/fulltext - DOI - PubMed

[9] Armstrong MJ, Adams LA, Canbay A, et al. . Extrahepatic complications of nonalcoholic fatty liver disease. Hepatology [Internet] 2014;59:1174–97. 10.1002/hep.26717 - DOI - PubMed

[10] Armstrong MJ, Adams LA, Canbay A, et al. . Extrahepatic complications of nonalcoholic fatty liver disease. Hepatology [Internet] 2014;59:1174–97. 10.1002/hep.26717 - DOI - PubMed

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

Affiliations

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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