MEDKIDS: Nutritional Intervention With Improved Bread and Bakery Products in Children With Overweight and Obesity

"Investigación y Desarrollo de Nuevos Productos Alimentarios Para la elaboración de Una Cesta Saludable Para alimentación Infantil": MEDKIDS. Intervención Nutricional Con Productos de Pan y bollería.

The goal of this randomized crossover clinical trial is to evaluate the effect of an intervention with nutritionally improved bread and bakery products on body composition and metabolic health in children aged 6 to 12 years with overweight or obesity.

The main questions it aims to answer are:

• Does consumption of reformulated bread and bakery products improve body composition compared to conventional products?
• Does the intervention improve lipid profile, inflammatory markers, gastrointestinal satiety-related peptides, and gut microbiota composition?

Researchers will compare conventional bakery products with reformulated products developed within the MEDKIDS project to determine their effects on anthropometric parameters, blood biomarkers, satiety, and intestinal microbiota.

Participants will:

• Follow a Mediterranean diet-based nutritional intervention with a 20% energy restriction adapted individually
• Consume either conventional or reformulated bread and bakery products during two 8-week intervention periods separated by a 5-week washout
• Undergo anthropometric assessments and blood, urine, and stool sample collection at the beginning and end of each period

Inclusion Criteria:

• Children aged 6 to 12 years.
• Overweight or obesity defined according to Cole et al. criteria.
• Willingness and commitment to consume the study bread and bakery products as part of the nutritional intervention.
• Written informed consent provided by a parent or legal guardian.

Exclusion Criteria:

• Diagnosed disorders related to glucose metabolism (e.g., diabetes mellitus).
• Celiac disease.
• Gastrointestinal disorders, including inflammatory bowel disease.
• Current medical or pharmacological treatment that may interfere with the study outcomes.