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临床试验/NCT04620057
NCT04620057已完成不适用

Effects of Oral Supplementation of Butyrate in Children With Obesity

Federico II University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
BMI z-score change

研究概览

简要总结

Worldwide obesity is a public health concern that is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. The main drivers of obesity pathogenesis seem to be a long-term of energy discrepancy between too many calories consumed and an increase of sedentary behavior. A growing body of evidence suggests that the set of microbes that live within the digestive tract, making up the gut microbiota (GM), play a metabolic role in energy regulation and substrate metabolism. Various factors can impact GM, one of these are dietary compounds that deeply affect the growth and metabolism of gut bacteria, since fermentation of nutrients is one core function of the intestinal microbes. Among fermentation products an array of small organic metabolites are short-chain fatty acids (SCFAs) acetate, propionate and butyrate. Among SCFAs, the C-4 fatty acid butyrate, the main fuel for the colonocytes, might have a potential in alleviating obesity and related metabolic complications. Butyrate could act as a regulator of body weight: a reasonable speculation is that butyrate acts on components of the energy balance, promoting energy expenditure and/or reducing energy intake. Preclinical studies have shown that butyrate supplementation prevent high-fat diet-induced obesity and it is able to treat obesity. With the sharp increase of obesity prevalence seen in the pediatric population, novel insights are necessary to counteract this epidemic disease, the outcome of the study is to see whether oral butyrate supplementation could exert similar effect in obese children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children/adolescents with diagnosis of obesity (BMI >95° percentile for age and sex) observed at Pediatric Section of Department of Translational Medical Sciences (University of Naples Federico II)

排除标准

  • Age at enrollment <5 or >17 years
  • BMI <95° percentile for age and sex
  • Patients under pharmacological treatment for obesity (metformin)
  • Patients assuming vitamin E,
  • Patients assuming pre-, pro- or synbiotics
  • Simultaneous presence of other chronic diseases unrelated to obesity:
  • immunodeficiency,
  • cystic fibrosis,
  • allergies,
  • celiac disease,
  • autoimmune diseases,
  • neuropsychiatric disorders,
  • type 1 diabetes,
  • inflammatory bowel diseases,
  • malformations of urinary or gastrointestinal or respiratory tract,
  • chronic lung diseases, genetic and metabolic diseases,
  • chronic hematological diseases.
  • History of surgery for the treatment of obesity
  • Any medical condition that may interfere with participation in this study
  • Participation in other clinical trials still in progress

结局指标

主要结局

BMI z-score change

时间窗: after 6 months from the start of intervention

BMI z-score change at least of ≥ 0.25

次要结局

  • waist circumference(after 6 months from the start of intervention)
  • HOMA index change(after 6 months from the start of intervention)
  • total cholesterol change(after 6 months from the start of intervention)
  • fasting glucose change(after 6 months from the start of intervention)
  • micro RNA 221- expression(after 6 months from the start of intervention)
  • fasting insulin change(after 6 months from the start of intervention)
  • Low density Lipoprotein cholesterol change(after 6 months from the start of intervention)
  • High density Lipoprotein cholesterol change(after 6 months from the start of intervention)
  • serum Interleukin-6(after 6 months from the start of intervention)
  • plasma triglycerides change(after 6 months from the start of intervention)
  • serum ghrelin(after 6 months from the start of intervention)
  • composition of the intestinal microbiota (metagenomics characteristics)(after 6 months from the start of intervention)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Berni Canani, MD, PhD

Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies

Federico II University

研究点 (2)

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