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Completed

NCT Number: NCT07786675

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

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.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zaragoza, 50009, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Intervention group

Conventional bread and bakery products

Other

Conventional bread and bakery products

Other names: Control group

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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: %

  7. 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.

  8. 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).

  9. 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.

  10. 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).

  11. 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.

Secondary outcomes

  1. Changes in sensory acceptability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Other Gov

Registry information

Official study 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.

Acronym: MEDKIDS

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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