Research

Projects

Research projects in which the GENUD group takes part.

Research

Ongoing projects · NUTRI-GENUD

11

CHIARA: cardiovascular health and lifestyle in Aragón adolescents

Project infographic: CHIARA: cardiovascular health and lifestyle in Aragón adolescents

CHIARA (Cardiovascular Health and Lifestyle in Aragón Adolescents) is a research project aimed at assessing cardiovascular health among adolescents in Aragón, Spain, and identifying how lifestyle behaviours, emotional well-being, and early-life factors may influence long-term cardiovascular health.

The project builds on the CALINA birth cohort, established in Aragón in 2009–2010, whose participants were followed throughout early childhood and reassessed at approximately 7 years of age. CHIARA introduces a new follow-up assessment at ages 16–17, providing a unique opportunity to investigate health trajectories from birth to late adolescence.

The study includes approximately 300 adolescents from Zaragoza, Huesca and Teruel. It combines comprehensive questionnaires covering dietary habits, physical activity, sleep, emotional health, social media use and socioeconomic circumstances with clinical assessments of anthropometry, body composition, physical fitness, blood pressure and blood biomarkers.

Cardiovascular health is assessed using the American Heart Association's Life's Essential 8 framework, which integrates eight lifestyle and cardiometabolic health components.

Through its longitudinal and multidisciplinary approach, CHIARA aims to improve our understanding of how early-life exposures, lifestyle behaviours and psychosocial well-being are associated with cardiovascular health during adolescence, supporting the development of early prevention strategies.

Funding
Instituto de Salud Carlos III (ISCIII)
Reference
PI23/01771
Principal investigators
Iris Iglesia Altaba, Gerardo Rodríguez Martínez

EXOMAIR: towards precision medicine in obesity, insulin resistance and metabolic health

Project infographic: EXOMAIR: towards precision medicine in obesity, insulin resistance and metabolic health

Adult obesity and its complications originate in early developmental events. Childhood obesity is a major risk factor for metabolic health across the life course, as it increases the risk of insulin resistance, the first step in metabolic deterioration. The EXOMAIR project (Towards Precision Medicine: Analysis of the Exposome and Omics using Explainable Artificial Intelligence to study their lifelong impact on obesity, insulin resistance and metabolic health) investigates how environmental factors, lifestyle habits and genetic and metabolic characteristics influence the development of obesity and insulin resistance from childhood to early adulthood.

Its objective is to assess the effect of exposure to environmental risks on cardiometabolic health in prospective cohorts of children with obesity, with particular attention to the metabolic, genetic and epigenetic alterations underlying the development of insulin resistance during puberty and their impact on metabolic health in that period and in early adulthood.

The project builds on two existing longitudinal cohorts, PUBMEP (n = 198) and IBEROMICs (n = 753), and combines exposomic and multi-omic approaches: a genome-wide association study (GWAS), analysis of global changes in blood DNA methylation (EWAS) and serum metabolomics. Lifestyle (diet and physical activity), the urban exposome and exposure to chemical substances are also characterised. All these longitudinal omic, clinical and exposomic data are integrated using explainable artificial intelligence (XAI) techniques to build comprehensive descriptive and predictive models.

These models will help improve the diagnosis, treatment and prediction of the risk of developing insulin resistance and/or obesity and its impact on later metabolic health, moving towards precision medicine that supports early identification of cardiometabolic risk and the design of personalised prevention programmes.

In the subproject led by Dr Gloria Bueno at the Aragon Health Research Institute (IIS Aragón), the GENUD team is responsible for methodological harmonisation and recruitment, nutritional assessment, accelerometry and questionnaires, processing and shipping of biological samples, data management, and statistical analysis and publication of results.

Funding
Instituto de Salud Carlos III (ISCIII), co-funded by the European Union
Reference
PI23/00191
Period
2024–2026
Principal investigators
María Gloria Bueno Lozano

GIraFFE: infant feeding and atopic dermatitis prevention

Project infographic: GIraFFE: infant feeding and atopic dermatitis prevention

GIraFFE (Goat Infant Formula Feeding and Eczema) is an international clinical trial investigating whether feeding infants a formula based on whole goat milk, compared with a cow milk-based formula, may reduce the risk of developing atopic dermatitis (eczema) during the first year of life.

The project involves 10 research centres across Spain and Poland and is designed to enrol up to 2,296 healthy term-born infants whose families have independently decided to use formula feeding, either exclusively or in combination with breastfeeding.

GIraFFE is a randomised, controlled, double-blind clinical trial in which participants receive one of the two study formulas until 12 months of age. Children are subsequently followed up until 5 years of age to investigate potential longer-term effects on child health.

In addition to assessing the incidence and severity of atopic dermatitis, the study examines other allergic conditions, growth and development, dietary intake, sleep, gastrointestinal health, gut microbiota, metabolism and quality of life.

GIraFFE aims to advance our understanding of the relationship between early-life nutrition, immune system development and the prevention of allergic diseases during childhood.

Principal investigators
Gerardo Rodríguez Martínez

SPHINX: early-life nutrition, skin barrier function and allergy prevention

Project infographic: SPHINX: early-life nutrition, skin barrier function and allergy prevention

SPHINX (Synbiotics in a Partially Hydrolyzed Formula to Improve Skin Barrier Function in Infants at Risk of Allergy) is a multicentre clinical trial investigating whether a partially hydrolysed infant formula supplemented with synbiotics (a combination of prebiotics and probiotics) can improve skin barrier function and potentially reduce the risk of atopic dermatitis in infants with a family history of allergy.

The study aims to enrol 400 healthy newborns at increased familial risk of allergy, allocated to three groups: two randomised, double-blind infant formula groups and a non-randomised reference group of exclusively breastfed infants.

The intervention takes place during the first 12 months of life, followed by assessments until 5 years of age to investigate the development of atopic dermatitis and other allergic conditions, including food allergies, allergic rhinitis and asthma.

The primary outcome is transepidermal water loss at 3 months of age, a non-invasive measure of skin barrier function. Additional assessments include skin hydration and health, growth, gastrointestinal tolerance, skin and gut microbiota, and immune and inflammatory biomarkers.

SPHINX aims to advance our understanding of how early-life nutrition may influence skin barrier maturation and immune development, providing evidence to support future strategies for preventing allergic diseases in early childhood.

Principal investigators
Gerardo Rodríguez Martínez

EarlyPROTECT: infant nutrition and immune system development

Project infographic: EarlyPROTECT: infant nutrition and immune system development

EarlyPROTECT is a multicentre clinical study sponsored by Laboratorios Ordesa, designed to evaluate the effects of an infant formula enriched with immunoprotective bioactive ingredients on immune system development and vaccination responses during early infancy.

This prospective, randomised, double-blind, controlled clinical trial compares three groups of healthy term infants: those receiving an infant formula enriched with immunoprotective ingredients, those fed a standard infant formula, and a reference group of exclusively breastfed infants.

The primary objective is to assess the immune response following the first routine vaccination through the measurement of vaccine-specific antibodies and biomarkers of cellular immunity, including the balance between Th1 and Th2 immune responses.

Secondary objectives include evaluating the incidence of infections and allergic manifestations, gut microbiota composition, gastrointestinal tolerance, infant growth, and formula safety.

Participants are assessed from approximately one month to four months of age through clinical visits, biological sample collection, and parent-reported health records.

EarlyPROTECT aims to advance scientific understanding of the relationship between early nutrition, immune maturation, and vaccination responses, contributing to research on nutritional strategies during a critical period of infant growth and development.

Funding
Laboratorios Ordesa (sponsor)
Principal investigators
Gerardo Rodríguez Martínez

FIT-PIV: enteral nutrition and intestinal health in preterm infants

Project infographic: FIT-PIV: enteral nutrition and intestinal health in preterm infants

FIT-PIV is an international, multicentre clinical trial designed to evaluate the efficacy and safety of an investigational enteral treatment containing recombinant human insulin (ELGN-2112) to improve intestinal feeding tolerance and absorption in preterm infants.

The study aims to enrol 420 preterm infants born between 26 and 31 completed weeks of gestation across approximately 50 research centres worldwide.

FIT-PIV is a randomised, double-blind, placebo-controlled trial in which participants receive either the investigational treatment or placebo alongside enteral feeding for up to 28 days.

The primary objective is to determine whether the treatment reduces the time required to achieve full enteral feeding, defined as an intake of at least 150 mL/kg/day for three consecutive days. Secondary outcomes include time to discontinuation of parenteral nutrition, growth, length of hospital stay, and neonatal complications, particularly necrotising enterocolitis and infections.

Participants are also followed until 24 months of corrected age to assess long-term safety, growth and neurodevelopmental outcomes.

FIT-PIV aims to generate scientific evidence on novel therapeutic approaches that may support intestinal maturation and function in very preterm infants, improve nutritional outcomes and potentially reduce complications associated with prematurity.

Principal investigators
Gerardo Rodríguez Martínez

RICORS-SAMID: Spanish Research Network on Maternal, Neonatal, Child and Developmental Health

Project infographic: RICORS-SAMID: Spanish Research Network on Maternal, Neonatal, Child and Developmental Health

RICORS-SAMID (Spanish Research Network on Maternal, Neonatal, Child and Developmental Health) is a nationwide collaborative research network funded by the Instituto de Salud Carlos III (ISCIII), bringing together 22 research groups from hospitals, universities and research institutions across Spain.

Its main objective is to improve the health and quality of life of pregnant women, newborns, children and adolescents through collaborative research, innovation and the translation of scientific knowledge into clinical practice.

The network implements a multidisciplinary research programme addressing major maternal and child health challenges, including pregnancy complications such as gestational diabetes and preeclampsia; environmental influences on health; prematurity and neurodevelopment; infection prevention; metabolic disorders; breastfeeding promotion; and early-life determinants of obesity and cardiovascular risk.

RICORS-SAMID also promotes integrated healthcare strategies for children with complex chronic conditions and supports the implementation of innovative technologies, digital tools and personalised medicine approaches in healthcare.

Through 12 interconnected work packages, the network fosters collaboration among healthcare professionals, researchers, families and patient organisations. Its activities include multicentre studies, researcher training and the translation of scientific findings into improved prevention, diagnosis and treatment strategies.

RICORS-SAMID aims to contribute to more preventive, personalised, integrated and family-centred healthcare, improving health outcomes from pregnancy through adolescence and reducing the lifelong burden of disease.

National coordination: Dr Elisa Llurba Olivé, Hospital de la Santa Creu i Sant Pau (Barcelona). Participation in Aragón: research group RG8, coordinated by Dr Gerardo Rodríguez Martínez, Hospital Clínico Universitario Lozano Blesa and Instituto de Investigación Sanitaria Aragón.

Funding
Instituto de Salud Carlos III (ISCIII)
Reference
RD24/0013
Principal investigators
Gerardo Rodríguez Martínez (grupo RG8, Aragón)

MELI-POP: growing healthily with a Mediterranean lifestyle

Project infographic: MELI-POP: growing healthily with a Mediterranean lifestyle

Childhood obesity can begin to develop during the early years of life, particularly when there is a family history of overweight or obesity. The MELI-POP project was launched to determine whether promoting a Mediterranean lifestyle based on a healthy diet and physical activity from the preschool years can help prevent obesity and its related consequences. To this end, we designed a multicentre randomized controlled trial (RCT), registered with ClinicalTrials.gov (NCT04597281), involving children aged 3 to 6 years with normal weight or overweight and at least one parent with overweight or obesity. The programme combines education on the Mediterranean diet and physical activity with the provision of foods such as extra-virgin olive oil and fish, together with physical activity sessions led by professionals [1].

The first results show that, after 12 months of intervention, participating children showed favourable changes in body composition, particularly among girls. In girls, the intervention was associated with reductions in body mass index and fat mass index compared with the control group. However, no significant differences between groups were observed in the cardiovascular risk factors assessed [2]. These findings suggest that promoting a Mediterranean lifestyle from an early age may help prevent excess adiposity in children at increased risk of developing obesity, although studies with larger sample sizes and longer follow-up are needed to confirm these effects.

One of the distinctive features of MELI-POP is that it does not focus solely on diet, but addresses different behaviours related to a healthy lifestyle as a whole. In addition to body composition, the project assesses dietary intake, physical activity, sedentary behaviour, sleep, physical fitness, and metabolic, inflammatory and cardiometabolic markers, as well as the gut microbiota and genetic, omic and metabolomic factors [1].

Funding
Instituto de Salud Carlos III (ISCIII), co-funded by the European Union
Reference
PI18/00666 · PI18/00930 · NCT04597281

References

  1. De Miguel-Etayo P, Flores-Rojas K, Vázquez-Cobela R, et al. MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial. BMC Public Health. 2025;25:3791. https://doi.org/10.1186/s12889-025-24351-2
  2. Larruy-García A, De Miguel-Etayo P, Gil-Campos M, et al. A Mediterranean lifestyle obesity prevention intervention in preschoolers at risk: MELI-POP Study—a randomized controlled trial. European Journal of Pediatrics. 2026;185(4):207. https://doi.org/10.1007/s00431-026-06844-3

DIVERSE: how lifestyle behaviours interact with metabolic health across the life course

Project infographic: DIVERSE: how lifestyle behaviours interact with metabolic health across the life course

Diet, physical activity, sedentary behaviour and sleep are closely interconnected and, together, can influence metabolic health. However, these behaviours are often studied separately. The DIVERSE project (Disentangling the Interplay between behaViours and biomarkERS across the lifEspan) aims to understand how these factors interact across different stages of life and how they are associated with metabolic health. To achieve this, the project integrates information from different population-based cohorts and biological samples, combining detailed lifestyle assessment with advanced metabolomics techniques and a circadian approach.

DIVERSE is a coordinated project comprising four subprojects, involving multidisciplinary research teams from several Spanish research centres. The study brings together three major cohorts covering different stages of life: MELIPOP, including children aged 3–6 years; IDEFICS/I.Family, including children and adolescents aged 7–14 years; and PESA, including adults aged 40–64 years. Overall, the project includes approximately 1,000 participants and makes use of detailed information on diet, physical activity, sedentary behaviour and sleep, together with blood samples for metabolomics analyses.

The project addresses this research question from different perspectives. P1 identifies new biomarkers and metabolic signatures associated with dietary patterns, physical activity, sedentary behaviour and sleep through metabolomics analyses. P2, led by IIS Aragón, investigates the associations between obesogenic dietary patterns, metabolic signatures, body composition and cardiometabolic health, while also contributing to improving dietary assessment by combining conventional methods with biomarkers. P3 develops and validates integrated methods to assess physical activity, sedentary behaviour and sleep across the 24-hour cycle. Finally, P4 integrates the information generated by the different subprojects to investigate the complex interplay between lifestyle factors, circadian rhythms and metabolic profiles.

One of the innovative aspects of DIVERSE is precisely the combination of traditional lifestyle assessment methods with exposure biomarkers obtained through metabolomics. This approach may improve the accuracy with which health-related behaviours are measured and help identify metabolic profiles associated with different combinations of diet, physical activity, sedentary behaviour and sleep. The project also considers how these relationships may vary according to age, sex and socioeconomic status.

DIVERSE aims to generate integrated tools to measure and monitor lifestyle behaviours and their interactions more accurately, helping to identify groups at higher risk and contributing to the design of health promotion and disease prevention strategies across the life course. One of the project's objectives is also to develop a “Lifestyle Metabolic Risk Score” (LMRS) integrating dietary, sleep, physical activity and sedentary behaviour profiles, and to investigate its potential to identify future alterations in metabolic and cardiovascular health.

Funding
Instituto de Salud Carlos III (ISCIII), co-funded by the European Union
Reference
PI22/01337 · PI22/00912 · PI22/01560 · PI22/01476

CORALS: understanding the factors that influence obesity risk from early childhood

Project infographic: CORALS: understanding the factors that influence obesity risk from early childhood

Childhood obesity is a complex health problem influenced by multiple factors related to the environment, diet and lifestyle. To understand how this risk develops from the early years of life, the CORALS (Childhood Obesity Risk Assessment Longitudinal Study) project established a multicentre prospective cohort of boys and girls aged 3 to 6 years, with annual data collection and a planned follow-up of approximately 10 years. The study brings together CIBEROBN research groups from seven Spanish cities: Barcelona, Córdoba, Pamplona, Reus, Santiago de Compostela, Valencia and Zaragoza.

The main aim of CORALS is to identify the factors that increase the risk of developing childhood obesity and to quantify the contribution of each of them. To achieve this, the study jointly assesses different aspects of lifestyle, such as diet, meal patterns, physical activity, sedentary behaviour and sleep patterns, among other factors. This longitudinal follow-up makes it possible to study how these factors interact over time and how they may influence changes in weight and child health.

One of the main strengths of CORALS is precisely its longitudinal perspective. Rather than analysing factors associated with obesity at a single point in time, the cohort makes it possible to observe how children's habits and characteristics change as they grow and how these changes are related to the development of overweight, obesity and other health-related outcomes. The study therefore aims to generate knowledge that can help identify children at higher risk at an early stage and guide future prevention strategies.

CORALS data are also contributing to new research into the relationship between diet, lifestyle and child health. Among the studies derived from the cohort is the development of MED4CHILD, a tool designed to assess adherence to the Mediterranean diet in childhood and examine its relationship with cardiometabolic health. In a sample of 858 boys and girls from the CORALS and MELIPOP cohorts, greater adherence to the Mediterranean diet was associated with a healthier cardiometabolic profile.

CORALS therefore provides a longitudinal knowledge base for understanding the early determinants of childhood obesity and its consequences, contributing to the development of earlier, more precise and better-tailored prevention strategies.

Funding
Instituto Danone Spain and CIBEROBN
Reference
OBN18PE05

B-Challenged: transforming environments to help children play and eat more healthily

Project infographic: B-Challenged: transforming environments to help children play and eat more healthily

Behaviours related to physical activity and diet do not depend solely on individual choices; they are also shaped by the places where children live, play, study and spend their free time. The European B-Challenged project was launched to improve the conditions that support active outdoor play and healthy dietary behaviours among children aged 6 to 12 years, particularly in urban neighbourhoods facing greater socioeconomic disadvantage. The project is being conducted in five European countries—Denmark, Germany, Poland, Spain and the Netherlands—and involves researchers, children, families, schools, local authorities and other community stakeholders.

B-Challenged uses a child-centred Participatory Action Research approach, combined with systems dynamics methods. Children themselves participate as co-researchers in identifying barriers and opportunities in their environments and in designing solutions. Based on the analysis of existing cohort data and participatory work with local communities, the project identifies the physical and social factors that influence active outdoor play and dietary behaviours. Children and adult stakeholders then co-create and implement actions aimed at transforming these environments and making them more supportive of healthy behaviours [1].

In Spain, the project is being implemented in a neighbourhood of Zaragoza and aims to connect scientific research with the needs and proposals of the local community. The goal is not to design solutions for children, but with children, incorporating their knowledge and experience into the transformation of their environment. This approach makes it possible to develop actions tailored to the characteristics of each neighbourhood while also generating models and tools that can be transferred to other urban contexts across Europe.

The project will evaluate whether the co-created actions contribute to changes within local systems and improve active outdoor play and healthy dietary behaviours among children. It will also assess how the participation process involving different stakeholders develops and whether child-centred Participatory Action Research contributes to increasing the sense of empowerment among children participating as co-researchers [1].

B-Challenged therefore proposes a new way of addressing childhood obesity prevention: not only by promoting changes in individual behaviours, but also by transforming the environments that make healthy behaviours possible, with the active participation of the community itself.

Funding
ERA4Health – HealthEquity (“Increasing health equity through promoting healthy diets and physical activity”), co-funded by the European Union (Horizon Europe). In Spain, Instituto de Salud Carlos III (ISCIII), AES-2023 International Collaboration Projects call
Reference
ERA4Health GA 101095426 · ISCIII AC23_2/00045

References

  1. Altenburg TM, Pawlowski CS, Ahrens W, et al. Promoting active outdoor play and healthy dietary behaviours through the co-creation of supporting physical and social environments for and with primary school-aged children living in underserved neighbourhoods in Europe: the protocol of the B-Challenged project. BMJ Open. 2026;16(3). https://doi.org/10.1136/bmjopen-2025-108281

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