The UFO (Ultra Processed Foods in Obesity) Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Dietary UPF intake
研究概览
简要总结
The childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide. This condition is the major risk factor for a set of metabolic abnormalities, also known as metabolic syndrome, a condition that reduce life expectancy by 5-20 years. Changes in the global food system, and the increased consumption of ultra-processed foods (UPFs), may have contributed to the increase in the prevalence of childhood obesity and related morbidities. The mechanisms by which UPFs might promote obesity and metabolic syndrome could be multiple and not completely identified.
The Ultra-processed Food in Obesity (UFO) Project has been designed to investigate the potential associations between UPFs intake and MetS in pediatric subjects
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian ethnicity, both sexes, age ≥6 and ≤18 years, diagnosis of obesity (Group 1), diagnosis of obesity and Metabolic Syndrome (Group 2), and age- and sex-matched healthy controls (Group 3).
排除标准
- •Non-Caucasian ethnicity;
- •Age <6 or >18 years;
- •Concomitant presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections,autoimmune diseases, chronic inflammatory bowel disease, celiac disease, metabolic-genetic diseases, cystic fibrosis and other chronic lung diseases, cardiovascular/respiratory/gastrointestinal malformations, neuropsychiatric disorders, and neurological disorders;
- •Intake of antibiotics and/or pre/pro/synbiotics;
- •History of obesity surgery and onset of diarrhea or acute gastrointestinal illness during the 12 weeks prior to enrollment;
- •Presence of tattoos, scars, moles or special lesions on both forearms.
研究组 & 干预措施
Group 1
Pediatric patients with obesity
Group 2
Pediatric patients with obesity complicated by Metabolic Syndrome
Group 3
Age- and sex-matched healthy controls
结局指标
主要结局
Dietary UPF intake
时间窗: At enrollment
The assessment of dietary UPF intake will be carried out through a 7-day food diary.
次要结局
- Skin AGEs levels(At enrollment)
- MicroRNA-221 expression(At enrollment)
- Daily dietary intake of AGEs(At enrollment)
- Mitochondrial metabolism(At enrollment)
- Ghrelin(At enrollment)
- Leptin(At enrollment)
- Soluble form of RAGE expression(At enrollment)
- Oxidative stress(At enrollment)
- Interleukin-6(At enrollment)
- Daily intake of energy and nutrients(At enrollment)
- RAGE expression in peripheral blood mononuclear cells(At enrollment)
研究者
Roberto Berni Canani, MD, PhD
Professor of Pediatrics
Federico II University