Clinical trial NCT04620057: Effects of Butyrate Against Pediatric Obesity
Official title: Effects of Oral Supplementation of Butyrate in Children With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 54
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria

* 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:

  * cancer,
  * 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

Primary outcomes:
measure: BMI z-score change
timeFrame: after 6 months from the start of intervention
Secondary outcomes:
measure: waist circumference
timeFrame: after 6 months from the start of intervention
measure: HOMA index change
timeFrame: after 6 months from the start of intervention
measure: fasting glucose change
timeFrame: after 6 months from the start of intervention
measure: fasting insulin change
timeFrame: after 6 months from the start of intervention
measure: total cholesterol change
timeFrame: after 6 months from the start of intervention
measure: Low density Lipoprotein cholesterol change
timeFrame: after 6 months from the start of intervention
measure: High density Lipoprotein cholesterol change
timeFrame: after 6 months from the start of intervention
measure: plasma triglycerides change
timeFrame: after 6 months from the start of intervention
measure: micro RNA 221- expression
timeFrame: after 6 months from the start of intervention
measure: serum ghrelin
timeFrame: after 6 months from the start of intervention
measure: serum Interleukin-6
timeFrame: after 6 months from the start of intervention
measure: composition of the intestinal microbiota (metagenomics characteristics)
timeFrame: after 6 months from the start of intervention
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References: