Distinct Exercise Modalities on GUT microbiome in Sarcopenic older adults (DEMGUTS): Study protocol of a pilot randomized controlled trial

Ana Sofia Merelim ^1,2 Rodrigo Zacca ^1,2 Daniel Moreira-Gonçalves ^1,2 Paulo Costa ^3,4 Liliana C. Baptista ^5,6*

• ¹ Faculty of Sports, University of Porto, Porto, Porto, Portugal
• ² Center for Research in Physical Activity, Health and Leisure, Faculty of Sports, University of Porto, Porto, Portugal
• ³ Unit for Multidisciplinary Research in Biomedicine, Abel Salazar Institute of Biomedical Sciences, University of Porto, Porto, Portugal
• ⁴ Departamento de Genética Humana, Instituto Nacional de Saúde Doutor Ricardo Jorge, Lisbon, Portugal
• ⁵ Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Coimbra, Portugal
• ⁶ Center for Research on Sport and Physical Activity, Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Coimbra, Portugal

Background: Sarcopenia is a progressive and age-related skeletal muscle disease related to adverse health outcomes and to an increased economic burden. Recent evidence pinpoints the human gut microbiota (GM) as a contributing factor in the development of sarcopenia via the gutmuscle axis. To date, no study specifically analysed the optimal type of exercise modality in older adults with sarcopenia considering the impact of GM composition in skeletal muscle mass and function. Therefore, the DEMGUTS study intents to explore the impact of three different exercise regimens on GM composition and gut-derived metabolites in older adults with sarcopenia.Methods: This pilot single center three-arm parallel open-label randomized control trial (RCT) will randomly assign eligible participants to: i) moderate aerobic exercise (AER); ii) resistance exercise (RES); or iii) concurrent exercise training (RES+AER). Participants will engage in a supervised center-based exercise intervention (12-weeks, 3d/week, 60min/d), and will be assessed at i) baseline, ii) end of intervention (14 weeks) and iii) at close-out (26-weeks). The primary outcome will be the change in the relative abundance of Faecalibacterium prausnitzii and other short-chain fatty acid producing bacteria after the intervention (14-weeks). A set of complementary outcomes will also be assessed to broadly characterize the impact of each exercise intervention on body composition, skeletal muscle function, functional performance and general GM composition.Unravelling the impact of these exercise regimens on GM is crucial to help clarify the optimal exercise modality to manage sarcopenia disease, contributing to clinical guidance and enhancing exercise prescription in older adults with sarcopenia.Clinicaltrial.gov: NCT06545123