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NCT06365567Completed

Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease.

Evaluation of Liver and Osteo-metabolic Complications Related to the Consumption of Fructose in a Cohort of Overweight and Obese Children and Adolescents.

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns, commercial factors, and social determinants; it has long-term consequences for both individual health and society as a whole. Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet, due to the increased availability of ultra-processed and more appealing foods, children and adolescents are shifting towards a "Western" diet. One in four children consumes sugary and carbonated drinks every day, which contributes to a high intake of fructose in the diet, while fruits and vegetables are consumed less, and legumes are included in the diet of only 38% of children less than once a week. Fructose is a monosaccharide naturally found in fruits, vegetables, and honey; due to its high sweetness and taste-enhancing properties, fructose is widely used in the food industry. High-fructose corn syrup, in particular, is one of the most widely used ingredients in the production of soft drinks, jams, breakfast cereals, and bakery products. Non-alcoholic fatty liver disease (NAFLD), now also called metabolic dysfunction-associated fatty liver disease (MAFLD), is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries. Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis, and indirectly through increased uric acid production. High-fructose foods also appear to be a risk factor for bone loss. Numerous studies conducted over the past 25 years, during which fructose consumption has exponentially increased, have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density (BMD) and new bone tissue deposition. The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age, and its effective relationship with the onset of liver and osteoarticular complications in this population. Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children.

Status (registry)
Completed
Study type
Observational
Enrollment
100 (actual)
First submitted
12 Feb 2024
Start date
4 Mar 2024
Primary completion date
5 Mar 2025
Lead sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Diseases
Obesity
NCT number
NCT06365567

What you commit to

  • Study type: Observational
  • Participants enrolled: 100
  • From 4 Mar 2024 to the primary completion date, 5 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Children and adolescents included in diet-therapy regimen with different dietary styles from the Mediterranean or Western diet (example ketogenic diet, FoadMap (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet, vegan/vegetarian diet) to avoid bias in the interpretation of the microbial signature (the microbial signature of the Western and Mediterranean diet is known in the literature);

Other illness

  • Children and adolescents with different liver diseases of NAFLD, as it is the interest of the study

Age

  • Children and adolescents not in that age group:

Other

  • Children and adolescents with genetic obesity or secondary obesity since the interest of the study is obesity caused by excessive calorie intake

Who the study is looking for

  • Children and adolescents of both sexes aged 3-6 years and 12-16 years, as interest groups for the assessment of hepatic steatosis induced by fructose consumption.
  • Children with overweight (defined by BMI \> 97 year old percentile for children under 5 years old; and BMI \>85 year old percentile for children over 5 years old) or obesity (defined by BMI \> 99 percentile for children under 5 years of age; and BMI \> 97 percentile for children over 5 years of age)

Age in the registry: 3 years to 16 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SCDU Pediatria, AOU Ospedale Maggiore della Carità
Coordinator of this site? Confirm its status
NovaraItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.