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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Reformulated bread and bakery products developed within the MEDKIDS project with improved nutritional profile, including reduced saturated fat and free sugars and increased dietary fiber content compared to conventional products.
Conventional bread and bakery products
Growth, Exercise, Nutrition and Development (GENUD) Research Group - University of Zaragoza
Zaragoza, Zaragoza, Spain
Changes in body weight
Change in body weight using bioelectrical impedance analysis with Tanita BC 780 MA scale. Unit of measure: kg
Time frame: Baseline and end of each 8-week intervention period
Change in height
Change in height measured using a Seca 225 precision stadiometer according to standardized anthropometric procedures. Unit of measure: cm
Time frame: Baseline and end of each 8-week intervention period
Change in body mass index
Change in body mass index calculated from body weight and height. Unir of measure: kg/m².
Time frame: Baseline and end of each 8-week intervention period
Change in body fat mass
Change in body fat mass using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unit of measure: kg
Time frame: Baseline and end of each 8-week intervention period
Change in lean body mass
Change in lean body mass using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unit of measure: Kg.
Time frame: Baseline and end of each 8-week intervention period
Change in total body water
Change in total body water measured using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unir of measure: %
Time frame: Baseline and end of each 8-week intervention period
Changes in triceps and subscapular skinfold thickness
Change in triceps and subscapular skinfold thickness measured in millimeters using a Holtain skinfold caliper according to standardized anthropometric procedures and International Society for the Advancement of Kinanthropometry (ISAK) recommendations. Three measurements will be performed.
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Time frame: Baseline and end of each 8-week intervention period
Changes in blood biochemical, lipid and inflammatory parameters
Changes in blood chemical, lipid, and inflammatory parameters measured from fasting blood samples. Biochemical parameters include glucose, total proteins, calcium, iron, and zinc concentrations. Lipid parameters include total cholesterol, HDL cholesterol, LDL cholesterol triglycerides, apolipoprotein A1, and apolipoprotein B. Inflammatory parameters include C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-10 (IL-10), complement component 3 (C3), and complement component 4 (C4).
Time frame: Baseline and end of each 8-week intervention period
Changes in gut microbiota composition and diversity
Changes in gut microbiota composition and diversity assessed from stool samples using metagenomic analysis following consumption of nutritionally improved versus conventional bread and bakery products.
Time frame: Baseline and end of each 8-week intervention period
Changes in satiety-related measures
Changes in circulating satiety-related gastrointestinal hormones measured from fasting blood samples. Gastrointestinal hormones include insulin, leptin, ghrelin, glucose-dependent insulinotropic polypeptide (GIP), pancreatic polypeptide (PP), and glucagon-like peptide-1 (GLP-1).
Time frame: Baseline and end of each 8-week intervention period
Change in arm, waist and hip circumference
Change in arm, waist and hip circumference circumference measured in centimeters using a measuring tape according to standardized anthropometric procedures and International Society for the Advancement of Kinanthropometry (ISAK) recommendations. Three measurements will be performed.
Time frame: Baseline and end of each 8-week intervention period
Changes in sensory acceptability
Changes in sensory acceptability assessed in the applied nutrition sensometry substudy using a nine-point hedonic scale. Participants rated the pleasantness of three characteristic aromas (chocolate, grass, and n-butanol) under standardized conditions after consumption of a standardized breakfast. Participants also indicated whether each aroma was familiar and completed an exploratory assessment of mood and emotions before and after food consumption using emoticons.
Time frame: Baseline and week 8