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临床试验/NCT06365567
NCT06365567招募中不适用

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

Azienda Ospedaliero Universitaria Maggiore della Carita1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
assessment of fructose intake with questionnaires

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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);

结局指标

主要结局

assessment of fructose intake with questionnaires

时间窗: 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 bone metabolism, detected through QUS

时间窗: 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

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

时间窗: 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

次要结局

  • 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)

研究者

发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavia Prodam

Professor

Azienda Ospedaliero Universitaria Maggiore della Carita

研究点 (1)

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