Pediatric ObesityEO2022NCT06365567
Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease.
An observational study of Pediatric Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Pediatric Obesity
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2024to 2 Mar 2026
- Phase
- Observational
- 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 3 to 16 years
- All sexes
- Child
Study population: 100 pediatric patients with overweight and obesity
Who may be able to join
- 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)
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Liver and Osteo-metabolic Complications Related to the Consumption of Fructose in a Cohort of Overweight and Obese Children and Adolescents.
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.
Read the detailed description
At the time of recruitment, patients referred to the Endocrinology Outpatient Clinic of the AOU (Azienda Ospedaliera Universitaria) Maggiore della Carità in Novara, the Transition Endocrinology Outpatient Clinic of the Endocrinology SCDU (Struttura Complessa a Direzione Universitaria), and the Pediatric Endocrinology Outpatient Clinic "B. Trambusti" of the Giovanni XXIII Pediatric Hospital, will undergo:
Questionnaires to assess the quantity of fructose intake through diet:
- KIDMED (quality index for children and adolescents) questionnaire to evaluate adherence to the Mediterranean diet in children/adolescents.
- IDEFICS (Identification and preven- tion of Dietary- and lifestyle- induced health EFfects In Children and infantS) questionnaire to assess food frequency in children.
- 24-hour recall questionnaire to gather information about meals consumed in the previous 24 hours. Macronutrient quantities will be obtained using dedicated software, "Professional Diet Therapy Software Dietosystem" from DSMedica(industry supplying the software). The questionnaire includes specific questions and figures to identify food portions and relate them to the quantity of fructose consumed.
- Calculation of the Dietary Inflammatory Index (DII) through a list of foods. This parameter allows for the determination of how much a dietary pattern promotes the synthesis of pro-inflammatory molecules.
- Sociological questionnaire prepared ad hoc by Unit 3 to assess dietary habits and fructose intake in relation to the family's socioeconomic status.
Anamnestic evaluation:
- The mother of the patient will be asked for gestational age, mode of delivery, and the child's birth anthropometric data.
- Recording of current pharmacological therapy (if present).
Instrumental evaluation:
- Quantitative and qualitative analysis of bone composition using quantitative ultrasound (QUS). This tool provides various parameters related to bone composition, specifically speed of sound (SOS) for bone density evaluation, broadband ultrasound attenuation (BUA) for trabecular structure evaluation, ultrasound peak amplitude for trabecular size evaluation, number of peaks for connectivity evaluation of the mineralized matrix structure, and energy and amplitude of fast waves for elasticity evaluation.
- Abdominal ultrasound (US) to assess hepatic steatosis, perivisceral and subcutaneous fat. The presence of hepatic steatosis (NAFLD) will be classified from stage 1 to stage 3 according to the literature.
Clinical-auxological evaluation:
- Anthropometric measurements including weight, height, and BMI according to STANDARD DEVIATION SCORE (SDS).
- Waist and hip circumference measurements.
- Measurement of blood pressure and heart rate.
- Analysis of body composition through bioimpedance analysis (BIA).
Expected results With this study, the investigators expect to acquire new knowledge about the effect of fructose on the onset of obesity-associated liver disease (NAFLD) and bone metabolism, by identifying new biological, immunological, and omics markers that can be studied in the future as disease targets in the pediatric population. Furthermore, due to scientific and sociological interest, this study aims to identify sociodemographic and cultural determinants related to fructose intake, which will be useful for creating preventive campaigns aimed at promoting a healthy lifestyle. This includes changing dietary habits to encourage a healthy diet and reducing obesity in the population.
- Conditions
- Pediatric Obesity
- Keywords
- pediatric, obesity, NAFLD, Fructose
- Medical subject headings
- Pediatric Obesity, Obesity, Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of fructose intake with questionnaires
assessment of fructose intake in preschool children and adolescent with obesity or overweight, using questionnaires with multiple answers
Measured: 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
Measured: 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
Measured: 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
Characterization of microorganisms present in the gastrointestinal tract and their microbial activity
Measured: Evaluation of microbiota after 12 months
Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers)
Evaluate sociodemographic and cultural determinants, and differences between Northern and Southern Italy through the use of questionnaires. Assessment scales will not be used, but will be a collection of data evaluated in a descriptive manner. There are no maximum and minimum, but what we will get from the questionnaires will be a descriptive overview of the population in Italy.
Measured: Evaluation of sociodemographic data after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start4 Mar 2024
- Primary completion5 Mar 2025
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Flavia Prodam, MD PHD, Principal investigator, AOU Maggiore della Carità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365567
- Sponsor's protocol ID
- CE209/2023
- Acronym
- EO2022
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19403716Alisi A, Carpino G, Nobili V. Paediatric nonalcoholic fatty liver disease. Curr Opin Gastroenterol. 2013 May;29(3):279-84. doi: 10.1097/MOG.0b013e32835ff95e.
PubMed 23493072Zhang 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.
PubMed 28353649Lanaspa 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.
PubMed 23112875Hostmark 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.
PubMed 21772969WHO 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.
PubMed 16817681Huybrechts 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.
PubMed 21483425Cavicchia 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.
PubMed 19864399Takahashi 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.
PubMed 25400438Nier 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.
PubMed 30235828Anderson 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.
PubMed 26512983
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver and Osteo-metabolic Complications Related to the Consumption of Fructose in a Cohort of Overweight and Obese Children and Adolescents.
- ClinicalTrials.gov ID
- NCT06365567
- Acronym / sponsor ID
- EO2022 / CE209/2023
- Conditions
- Pediatric Obesity
- Keywords
- pediatric, obesity, NAFLD, Fructose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 15 Apr 2024 (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 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.
Detailed description
At the time of recruitment, patients referred to the Endocrinology Outpatient Clinic of the AOU (Azienda Ospedaliera Universitaria) Maggiore della Carità in Novara, the Transition Endocrinology Outpatient Clinic of the Endocrinology SCDU (Struttura Complessa a Direzione Universitaria), and the Pediatric Endocrinology Outpatient Clinic "B. Trambusti" of the Giovanni XXIII Pediatric Hospital, will undergo:
Questionnaires to assess the quantity of fructose intake through diet:
- KIDMED (quality index for children and adolescents) questionnaire to evaluate adherence to the Mediterranean diet in children/adolescents.
- IDEFICS (Identification and preven- tion of Dietary- and lifestyle- induced health EFfects In Children and infantS) questionnaire to assess food frequency in children.
- 24-hour recall questionnaire to gather information about meals consumed in the previous 24 hours. Macronutrient quantities will be obtained using dedicated software, "Professional Diet Therapy Software Dietosystem" from DSMedica(industry supplying the software). The questionnaire includes specific questions and figures to identify food portions and relate them to the quantity of fructose consumed.
- Calculation of the Dietary Inflammatory Index (DII) through a list of foods. This parameter allows for the determination of how much a dietary pattern promotes the synthesis of pro-inflammatory molecules.
- Sociological questionnaire prepared ad hoc by Unit 3 to assess dietary habits and fructose intake in relation to the family's socioeconomic status.
Anamnestic evaluation:
- The mother of the patient will be asked for gestational age, mode of delivery, and the child's birth anthropometric data.
- Recording of current pharmacological therapy (if present).
Instrumental evaluation:
- Quantitative and qualitative analysis of bone composition using quantitative ultrasound (QUS). This tool provides various parameters related to bone composition, specifically speed of sound (SOS) for bone density evaluation, broadband ultrasound attenuation (BUA) for trabecular structure evaluation, ultrasound peak amplitude for trabecular size evaluation, number of peaks for connectivity evaluation of the mineralized matrix structure, and energy and amplitude of fast waves for elasticity evaluation.
- Abdominal ultrasound (US) to assess hepatic steatosis, perivisceral and subcutaneous fat. The presence of hepatic steatosis (NAFLD) will be classified from stage 1 to stage 3 according to the literature.
Clinical-auxological evaluation:
- Anthropometric measurements including weight, height, and BMI according to STANDARD DEVIATION SCORE (SDS).
- Waist and hip circumference measurements.
- Measurement of blood pressure and heart rate.
- Analysis of body composition through bioimpedance analysis (BIA).
Expected results With this study, the investigators expect to acquire new knowledge about the effect of fructose on the onset of obesity-associated liver disease (NAFLD) and bone metabolism, by identifying new biological, immunological, and omics markers that can be studied in the future as disease targets in the pediatric population. Furthermore, due to scientific and sociological interest, this study aims to identify sociodemographic and cultural determinants related to fructose intake, which will be useful for creating preventive campaigns aimed at promoting a healthy lifestyle. This includes changing dietary habits to encourage a healthy diet and reducing obesity in the population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- 100 pediatric patients with overweight and obesity
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assessment of fructose intake with questionnaires
Time frame: evaluation of fructose intake through study completion, an average of 1 year
assessment of fructose intake in preschool children and adolescent with obesity or overweight, using questionnaires with multiple answers
correlation of fructose consumption with hepatic complications, detected trough echo-abdomen and blood analysis
Time frame: assessment of fructose intake in correlation with hepatic complications through study completion, an average of 1 year
assessment of fructose intake in correlation with hepatic complications using echo-abdomen and blood analysis as detection methods
Correlation of fructose consumption with bone metabolism, detected through QUS
Time frame: assessment of fructose intake in correlation with bone metabolism through study completion, an average of 1 year
assessment of fructose intake in correlation with bone metabolism, using QUS as detection method
2 secondary outcomes
Characterization of the concentration of intestinal microorganisms
Time frame: Evaluation of microbiota after 12 months
Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers)
Time frame: Evaluation of sociodemographic data after 12 months
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 28 Oct 2026.
- Background: PubMed 19403716Marriott 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.
- Background: PubMed 23493072Alisi A, Carpino G, Nobili V. Paediatric nonalcoholic fatty liver disease. Curr Opin Gastroenterol. 2013 May;29(3):279-84. doi: 10.1097/MOG.0b013e32835ff95e.
- Background: PubMed 28353649Zhang 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.
- Background: PubMed 23112875Lanaspa 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.
- Background: PubMed 21772969Hostmark 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.
- Background: PubMed 16817681WHO 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.
- Background: PubMed 21483425Huybrechts 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.
- Background: PubMed 19864399Cavicchia 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.
- Background: PubMed 25400438Takahashi 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.
- Background: PubMed 30235828Nier 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.
- Background: PubMed 26512983Anderson 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.
- Individual participant dataSharing planned: No
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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.
Flavia Prodam, MD PHD principal investigator
AOU Maggiore della Carità
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
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 2 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 28 Oct 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 Italy. 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?
assessment of fructose intake with questionnaires (time frame: evaluation of fructose intake through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06365567, which also lists 11 linked publications.
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 28 Oct 2026.