MEDKIDS
"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.
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Centro para el Desarrollo Tecnológico e Industrial (CDTI). Convocatoria CIEN
interventional
60
1 country
1
Study Start
October 1, 2021
Actual (reported)Primary Completion
November 30, 2022
Actual (reported)Study Completion
March 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2021
Actual (reported)November 30, 2022
Actual (reported)March 31, 2023
Actual (reported)March 25, 2026
Actual (reported)August 26, 2026
Actual (reported)Changes in body weight
Change in body weight using bioelectrical impedance analysis with Tanita BC 780 MA scale. Unit of measure: kg
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
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.
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
Baseline and end of each 8-week intervention period
Changes in sensory acceptability
Baseline and week 8
Participants consume nutritionally improved bread and bakery products developed within the MEDKIDS project during one 8-week period as part of a randomized crossover clinical trial, with their habitual diet.
Participants consume conventional bread and bakery products used as reference products during one 8-week period within a randomized crossover clinical trial, with their habitual diet.
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.
Growth, Exercise, Nutrition and Development (GENUD) Research Group - University of Zaragoza
Zaragoza, Zaragoza, 50009, Spain
Luis A Moreno
Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza (Spain)
60 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2026
First Posted
August 26, 2026
Study Start
October 1, 2021
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.
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: %
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.
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).
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.
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).
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.
Baseline and end of each 8-week intervention period
Conventional bread and bakery products
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 30, 2022
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Last Updated
August 26, 2026
Record last verified: 2026-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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