An interventional study of Nutritionally improved bread and bakery products and Conventional bread and bakery products in Pediatric Obesity, sponsored by Consorcio Centro de Investigación Biomédica en Red (CIBER). Completed at 1 site in Spain. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Consorcio Centro de Investigación Biomédica en Red (CIBER) · Not applicable, Interventional, and Treatment
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:
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:
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Consorcio Centro de Investigación Biomédica en Red (CIBER) is the lead sponsor of 18 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Nutritionally improved bread and bakery products
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.
Other: Conventional 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.
Also known as: Intervention group
Conventional bread and bakery products
Also known as: Control group
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2021 to primary completion in Nov 2022, 13 months.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 13 months is below that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Consorcio Centro de Investigación Biomédica en Red (CIBER)