Pediatric ObesityMEDKIDSNCT07786675
MEDKIDS: Nutritional Intervention With Improved Bread and Bakery Products in Children With Overweight and Obesity
A study testing Nutritionally improved bread and bakery products and Conventional bread and bakery products in people with Pediatric Obesity, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Nutritionally improved bread and bakery products and Conventional bread and bakery products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Growth, Exercise, Nutrition and Development (GENUD) Research Group - University of Zaragoza
Zaragoza, Zaragoza, 50009
About this study
Official title: "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.
Read the 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
- Conditions
- Pediatric Obesity
- Being tested
- Nutritionally improved bread and bakery products, Conventional bread and bakery products
- Keywords
- mediterranean diet, dietary intervention, bakery products, whole grain, childhood obesity, gut microbiota, inflammation, lipid profile, satiety
- Medical subject headings
- Pediatric Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritionally improved bread and bakery productsOther
Also called Intervention group
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 productsOther
Also called Control group
Conventional bread and bakery products
| Study group | Role | What they receive |
|---|---|---|
| Nutritionally improved bread and bakery products | Experimental | 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. Receives: Other: Nutritionally improved bread and bakery products |
| Conventional bread and bakery products | Active comparator | 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. Receives: Other: Conventional bread and bakery products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Change in body weight using bioelectrical impedance analysis with Tanita BC 780 MA scale. Unit of measure: kg
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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: %
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and end of each 8-week intervention period
Secondary outcomes (1)
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.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Oct 2021
- Primary completion30 Nov 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized two-period crossover trial with two 8-week intervention periods separated by a 5-week washout.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Luis A Moreno, Principal investigator, Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786675
- Sponsor's protocol ID
- IDI-20190981
- Other IDs
- IDI-20190981
- Acronym
- MEDKIDS
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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.
- ClinicalTrials.gov ID
- NCT07786675
- Acronym / sponsor ID
- MEDKIDS / IDI-20190981
- Conditions
- Pediatric Obesity
- Keywords
- mediterranean diet, dietary intervention, bakery products, whole grain, childhood obesity, gut microbiota, inflammation, lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized two-period crossover trial with two 8-week intervention periods separated by a 5-week washout.
| Arm | Type | Receives |
|---|---|---|
| Nutritionally improved bread and bakery products | Experimental | Other: Nutritionally improved bread and bakery productsParticipants 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. |
| Conventional bread and bakery products | Active comparator | Other: Conventional bread and bakery productsParticipants 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritionally improved bread and bakery productsAlso: Intervention groupReformulated 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. | Other | Nutritionally improved bread and bakery products |
| Conventional bread and bakery productsAlso: Control groupConventional bread and bakery products | Other | Conventional bread and bakery products |
Primary outcome
Changes in body weight
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Changes in sensory acceptability
Time frame: Baseline and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A Moreno principal investigator
Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza (Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritionally improved bread and bakery products and Conventional bread and bakery products in people with Pediatric Obesity, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: Baseline and end of each 8-week intervention period). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.