Pediatric Obesity
Conditions
Keywords
mediterranean diet, dietary intervention, bakery products, whole grain, childhood obesity, gut microbiota, inflammation, lipid profile, satiety
Brief summary
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.
Detailed description
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
Interventions
OTHERNutritionally improved bread and bakery products
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.
OTHERConventional bread and bakery products
Conventional bread and bakery products
Sponsors
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label dietary intervention; masking is not feasible due to the nature of the food products.
Intervention model description
Randomized two-period crossover trial with two 8-week intervention periods separated by a 5-week washout.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight | Baseline and end of each 8-week intervention period | Change in body weight using bioelectrical impedance analysis with Tanita BC 780 MA scale. Unit of measure: kg |
| Change in height | Baseline and end of each 8-week intervention period | Change in height measured using a Seca 225 precision stadiometer according to standardized anthropometric procedures. Unit of measure: cm |
| Change in body mass index | Baseline and end of each 8-week intervention period | Change in body mass index calculated from body weight and height. Unir of measure: kg/m². |
| Change in body fat mass | Baseline and end of each 8-week intervention period | Change in body fat mass using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unit of measure: kg |
| Change in lean body mass | Baseline and end of each 8-week intervention period | Change in lean body mass using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unit of measure: Kg. |
| Change in total body water | Baseline and end of each 8-week intervention period | Change in total body water measured using bioelectrical impedance analysis with a Tanita BC 780 MA scale. Unir of measure: % |
| Changes in triceps and subscapular skinfold thickness | Baseline and end of each 8-week intervention period | 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. |
| Changes in blood biochemical, lipid and inflammatory parameters | Baseline and end of each 8-week intervention period | 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). |
| Changes in gut microbiota composition and diversity | Baseline and end of each 8-week intervention period | 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. |
| Changes in satiety-related measures | Baseline and end of each 8-week intervention period | 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). |
| Change in arm, waist and hip circumference | Baseline and end of each 8-week intervention period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sensory acceptability | Baseline and week 8 | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORLuis A Moreno
Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza (Spain)
Outcome results
None listed