Brain and heart conditions are among the leading causes of illness and mortality in Canada. Heart failure is one of the fastest-growing cardiovascular conditions globally, with more than 100 000 Canadians diagnosed each year. Individuals with heart failure are at significantly increased risk of mental health challenges such as depression, anxiety and stress. However, healthcare services often remain siloed, treating physical and mental health separately. This complicates care for individuals with multiple chronic conditions. This multiyear study will adapt, test and accelerate changes to regional care delivery models in Eastern Ontario to optimise brain-heart health and generate knowledge to support the spread and scale of effective interventions that address community needs and priorities. We aim to: (1) identify resource gaps by mapping available services; (2) document strengths and challenges in care delivery; and (3) co-design, pilot test and evaluate an intervention developed based on the priority gap area(s) identified through objectives (1) and (2).

This community-based participatory action research study is led by a research coalition of patient and caregiver partners, care providers and leadership staff from two Ontario Health Teams. In Year 1, we will conduct asset mapping and community consultations with individuals living with heart failure, caregivers, care providers and service organisations to identify care gaps, strengths and opportunities for improvement around modifiable behavioural risk factors and brain-heart health. A scoping review will identify evidence-based strategies to address care gaps and inform the co-design of an intervention focused on supporting individuals with brain-heart interconnected conditions. In Year 2, we will co-design an intervention with community partners for implementation with clinical test sites. Year 3 will involve pilot testing the intervention and conducting outcome and process evaluations. This will inform future spread and scale of the intervention to other brain-heart conditions and new jurisdictions.

The study is approved by the Bruyère Health Research Ethics Board (M16-24-016). Findings will be disseminated through peer-reviewed publications, conference presentations and knowledge mobilisation activities such as social media, community events and local media outreach, as well as through dedicated engagement with Ontario Health partners and the Brain-Heart Interconnectome Network via retreats and collaborative forums.

Adolescence and youth are periods of significant maturational changes, which seem to involve greater susceptibility to disruptive events in the brain, such as binge drinking (BD). This pattern—characterised by repeated episodes of alcohol intoxication—is of particular concern, as it has been associated with significant alterations in the developing brain. Recent evidence indicates that alcohol may also induce changes in gut microbiota composition and that such disturbances can lead to impairments in both brain function and behaviour. Moreover, there is evidence suggesting that microbiota-targeted interventions (psychobiotics) may help mitigate alcohol-induced damage in individuals with chronic alcohol use, positively influencing cognitive and brain functioning. However, the triadic relationship between BD, gut microbiota and brain structure/function, as well as the therapeutic potential of gut microbiota-targeted interventions in young binge drinkers, remains largely unexplored.

This double-blind, parallel, randomised controlled study aims to evaluate whether a BD pattern disrupts gut microbiota diversity in young college students (primary outcome). Additionally, it seeks to determine whether alcohol-induced alterations in the microbial composition and function are associated with immunological, cognitive, neurostructural and neurofunctional impairments (secondary outcomes). A total of 82 college students (36 non/low drinkers and 46 binge drinkers (BDs)), matched for age and sex, will be recruited from the University of Minho (Portugal). During the pre-intervention phase, all participants will undergo a comprehensive assessment protocol, including gut microbiota profiling, measurement of inflammatory markers, neuropsychological testing and structural and functional MRI. BDs will then be randomly assigned to a 6-week intervention with either a prebiotic (inulin) or a placebo (maltodextrin). Post-intervention assessment will mirror the baseline protocol, and craving and alcohol use will be monitored for 3 months.

The present protocol was approved by the Ethics Committee for Social and Human Sciences of the University of Minho (CEICSH 078/2022), ensuring compliance with national and international ethical guidelines, including the Declaration of Helsinki. Participation is voluntary and preceded by informed consent, with confidentiality and data processing safeguarded in accordance with the General Data Protection Regulation. All procedures are safe and non-invasive, and the prebiotics used are recognised as food ingredients in Europe, hold Generally Recognized as Safe status in the USA and are classified as dietary fibres by the Food and Drug Administration. Findings will be disseminated in national and international scientific forums, with preference for publication in open-access, peer-reviewed journals.

NCT05946083