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

NCT06365567 | Recruiting

• 1 other identifier: CE209/2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Obesity

Keywords

pediatric; obesity; NAFLD; Fructose

Outcome Measures

Primary Outcomes (3)

• assessment of fructose intake with questionnaires

  assessment of fructose intake in preschool children and adolescent with obesity or overweight, using questionnaires with multiple answers

  evaluation of fructose intake through study completion, an average of 1 year

• correlation of fructose consumption with hepatic complications, detected trough echo-abdomen and blood analysis

  assessment of fructose intake in correlation with hepatic complications using echo-abdomen and blood analysis as detection methods

  assessment of fructose intake in correlation with hepatic complications through study completion, an average of 1 year

• Correlation of fructose consumption with bone metabolism, detected through QUS

  assessment of fructose intake in correlation with bone metabolism, using QUS as detection method

  assessment of fructose intake in correlation with bone metabolism through study completion, an average of 1 year

Secondary Outcomes (2)

• Characterization of the concentration of intestinal microorganisms

  Evaluation of microbiota after 12 months

• Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers)

  Evaluation of sociodemographic data after 12 months

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

100 pediatric patients with overweight and obesity

You may qualify if:

• 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)

You may not qualify if:

• Children and adolescents not in that age group:
• Children and adolescents with different liver diseases of NAFLD, as it is the interest of the study
• Children and adolescents with genetic obesity or secondary obesity since the interest of the study is obesity caused by excessive calorie intake
• 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);

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator

Study Sites (1)

SCDU Pediatria, AOU Ospedale Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (11)

• Marriott BP, Cole N, Lee E. National estimates of dietary fructose intake increased from 1977 to 2004 in the United States. J Nutr. 2009 Jun;139(6):1228S-1235S. doi: 10.3945/jn.108.098277. Epub 2009 Apr 29.

  PMID: 19403716 BACKGROUND

• Alisi A, Carpino G, Nobili V. Paediatric nonalcoholic fatty liver disease. Curr Opin Gastroenterol. 2013 May;29(3):279-84. doi: 10.1097/MOG.0b013e32835ff95e.

  PMID: 23493072 BACKGROUND

• Zhang DM, Jiao RQ, Kong LD. High Dietary Fructose: Direct or Indirect Dangerous Factors Disturbing Tissue and Organ Functions. Nutrients. 2017 Mar 29;9(4):335. doi: 10.3390/nu9040335.

  PMID: 28353649 BACKGROUND

• Lanaspa MA, Sanchez-Lozada LG, Cicerchi C, Li N, Roncal-Jimenez CA, Ishimoto T, Le M, Garcia GE, Thomas JB, Rivard CJ, Andres-Hernando A, Hunter B, Schreiner G, Rodriguez-Iturbe B, Sautin YY, Johnson RJ. Uric acid stimulates fructokinase and accelerates fructose metabolism in the development of fatty liver. PLoS One. 2012;7(10):e47948. doi: 10.1371/journal.pone.0047948. Epub 2012 Oct 24.

  PMID: 23112875 BACKGROUND

• Hostmark AT, Sogaard AJ, Alvaer K, Meyer HE. The oslo health study: a dietary index estimating frequent intake of soft drinks and rare intake of fruit and vegetables is negatively associated with bone mineral density. J Osteoporos. 2011;2011:102686. doi: 10.4061/2011/102686. Epub 2011 Jul 2.

  PMID: 21772969 BACKGROUND

• WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards based on length/height, weight and age. Acta Paediatr Suppl. 2006 Apr;450:76-85. doi: 10.1111/j.1651-2227.2006.tb02378.x.

  PMID: 16817681 BACKGROUND

• Huybrechts I, Bornhorst C, Pala V, Moreno LA, Barba G, Lissner L, Fraterman A, Veidebaum T, Hebestreit A, Sieri S, Ottevaere C, Tornaritis M, Molnar D, Ahrens W, De Henauw S; IDEFICS Consortium. Evaluation of the Children's Eating Habits Questionnaire used in the IDEFICS study by relating urinary calcium and potassium to milk consumption frequencies among European children. Int J Obes (Lond). 2011 Apr;35 Suppl 1:S69-78. doi: 10.1038/ijo.2011.37.

  PMID: 21483425 BACKGROUND

• Cavicchia PP, Steck SE, Hurley TG, Hussey JR, Ma Y, Ockene IS, Hebert JR. A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein. J Nutr. 2009 Dec;139(12):2365-72. doi: 10.3945/jn.109.114025. Epub 2009 Oct 28.

  PMID: 19864399 BACKGROUND

• Takahashi Y, Fukusato T. Histopathology of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. World J Gastroenterol. 2014 Nov 14;20(42):15539-48. doi: 10.3748/wjg.v20.i42.15539.

  PMID: 25400438 BACKGROUND

• Nier A, Brandt A, Conzelmann IB, Ozel Y, Bergheim I. Non-Alcoholic Fatty Liver Disease in Overweight Children: Role of Fructose Intake and Dietary Pattern. Nutrients. 2018 Sep 19;10(9):1329. doi: 10.3390/nu10091329.

  PMID: 30235828 BACKGROUND

• Anderson EL, Howe LD, Jones HE, Higgins JP, Lawlor DA, Fraser A. The Prevalence of Non-Alcoholic Fatty Liver Disease in Children and Adolescents: A Systematic Review and Meta-Analysis. PLoS One. 2015 Oct 29;10(10):e0140908. doi: 10.1371/journal.pone.0140908. eCollection 2015.

  PMID: 26512983 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Flavia Prodam, MD PHD

  AOU Maggiore della Carità

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavia Prodam, MD PHD

CONTACT

+39-0321-660693; flavia.prodam@med.uniupo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: April 15, 2024
• Study Start: March 4, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 2, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)