MEDKIDS: Nutritional Intervention With Improved Bread and Bakery Products in Children With Overweight and Obesity

NCT07786675 | Completed

• 1 other identifier: IDI-20190981
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

mediterranean diet; dietary intervention; bakery products; whole grain; childhood obesity; gut microbiota; inflammation; lipid profile; satiety

Outcome Measures

Primary Outcomes (11)

• 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

• 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

Secondary Outcomes (1)

• Changes in sensory acceptability

  Baseline and week 8

Study Arms (2)

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.

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.

Other: Conventional bread and bakery products

Interventions

Nutritionally improved bread and bakery products OTHER

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

Nutritionally improved bread and bakery products

Conventional bread and bakery products OTHER

Conventional bread and bakery products

Also known as: Control group

Conventional bread and bakery products

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead

Study Sites (1)

Growth, Exercise, Nutrition and Development (GENUD) Research Group - University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Pediatric Obesity; Inflammation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Luis A Moreno

  Growth, Exercise, Nutrition and Development (GENUD) Research Group, University of Zaragoza (Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label dietary intervention; masking is not feasible due to the nature of the food products.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized two-period crossover trial with two 8-week intervention periods separated by a 5-week washout.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: August 26, 2026
• Study Start: October 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: March 31, 2023
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

ES (1)