Effects of Butyrate Against Pediatric Obesity (BAPO)

Federico II University

Status: Completed

Conditions: Obesity, Childhood

Treatments: Other: placebo; Dietary Supplement: butyrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04620057

29ES20

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Butyrate + standard care for pediatric obesity

Experimental group

Description:

standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day)

Treatment:

Dietary Supplement: butyrate

placebo + standard care for pediatric obesity

Placebo Comparator group

Description:

standard care for pediatric obesity + placebo (cornstarch)

Treatment:

Other: placebo