Protein–energy malnutrition and the subsequent muscle wasting (sarcopenia) are common ageing complications. It is knowing to be also associated with dementia. Our programme will test the cytoprotective functions of vitamin E combined with the cortisol-lowering effect of chocolate polyphenols (PP), in combination with muscle anabolic effect of adequate dietary protein intake and physical exercise to prevent the age-dependent decline of muscle mass and its key underpinning mechanisms including mitochondrial function, and nutrient metabolism in muscle in the elderly.

In 2020, a 6-month double-blind randomised controlled trial in 75 predementia older people was launched to prevent muscle mass loss, in respond to the ‘Joint Programming Initiative A healthy diet for a healthy life’. In the run-in phase, participants will be stabilised on a protein-rich diet (0.9–1.0 g protein/kg ideal body weight/day) and physical exercise programme (high-intensity interval training specifically developed for these subjects). Subsequently, they will be randomised into three groups (1:1:1). The study arms will have a similar isocaloric diet and follow a similar physical exercise programme. Control group (n=25) will maintain the baseline diet; intervention groups will consume either 30 g/day of dark chocolate containing 500 mg total PP (corresponding to 60 mg epicatechin) and 100 mg vitamin E (as RRR-alpha-tocopherol) (n=25); or the high polyphenol chocolate without additional vitamin E (n=25). Muscle mass will be the primary endpoint. Other outcomes are neurocognitive status and previously identified biomolecular indices of frailty in predementia patients. Muscle biopsies will be collected to assess myocyte contraction and mitochondrial metabolism. Blood and plasma samples will be analysed for laboratory endpoints including nutrition metabolism and omics.

All the ethical and regulatory approvals have been obtained by the ethical committees of the Azienda Ospedaliera Universitaria Integrata of Verona with respect to scientific content and compliance with applicable research and human subjects’ regulation. Given the broader interest of the society toward undernutrition in the elderly, we identify four main target audiences for our research activity: national and local health systems, both internal and external to the project; targeted population (the elderly); general public; and academia. These activities include scientific workshops, public health awareness campaigns, project dedicated website and publication is scientific peer-review journals.

NCT05343611.

Nutrition during the complementary feeding period (6–23 months) is critical to ensure optimal growth and reduce the risk of diet-related disease across the life course. Strategies to reduce multiple forms of malnutrition (stunting, overweight/obesity and anaemia) in infants and young children (IYC) are a key priority in low-income and middle-income countries, including Peru. This study aims to co-design and develop prototypes for interventions to address the multiple forms of malnutrition in IYC in urban Peru, using a participatory design approach.

The study will be based within peri-urban communities in two areas of Peru (Lima and Huánuco city). Following the identification of key nutritional challenges for IYC aged 6–23 months through formative research (phase I), we will conduct a series of workshops bringing together healthcare professionals from government health centres and caregivers of IYC aged 6–23 months. Workshops (on idea generation; creating future scenarios; storyboarding and early implementation and feedback) will take place in parallel in the two study areas. Through these workshops, we will engage with community participants to explore, experiment, co-design and iteratively validate new design ideas to address the challenges around IYC complementary feeding from phase I. Workshop outputs and transcripts will be analysed qualitatively using affinity diagramming and thematic analyses. The intervention prototypes will be evaluated qualitatively and piloted with the participating communities.

Ethical approval for this study was obtained from the Ethical Review Committee of the Instituto de Investigación Nutricional (IIN) Peru (388-2019/CIEI-IIN), Loughborough University (C19-87) and confirmed by Cardiff University. Findings of the participatory design process will be disseminated through a deliberative workshop in Lima, Peru with national and regional government stakeholders, as well as participants and researchers involved in the design process. Further dissemination will take place through policy briefs, conferences and academic publications.