Effects of Butyrate Against Pediatric Obesity (BAPO)

Effects of Oral Supplementation of Butyrate in Children With Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Dietary supplement: butyrate; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Butyrate + standard care for pediatric obesity; standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day)	Dietary supplement: butyrate; sodium butyrate (20 mg/kg body weight/day)
Placebo Comparator: placebo + standard care for pediatric obesity; standard care for pediatric obesity + placebo (cornstarch)	Other: placebo; cornstarch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI z-score change	BMI z-score change at least of ≥ 0.25	after 6 months from the start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist circumference	mean waist circumference change	after 6 months from the start of intervention
HOMA index change	mean of HOMA index change	after 6 months from the start of intervention
fasting glucose change	mean of fasting glucose change	after 6 months from the start of intervention
fasting insulin change	mean of fasting insulin change	after 6 months from the start of intervention
total cholesterol change	mean of total cholesterol change	after 6 months from the start of intervention
Low density Lipoprotein cholesterol change	mean of Low density Lipoprotein cholesterol change	after 6 months from the start of intervention
High density Lipoprotein cholesterol change	mean of high density Lipoprotein cholesterol change	after 6 months from the start of intervention
plasma triglycerides change	mean of plasma triglycerides change	after 6 months from the start of intervention
micro RNA 221- expression	mean of mir221- expression	after 6 months from the start of intervention
serum ghrelin	mean of serum ghrelin	after 6 months from the start of intervention
serum Interleukin-6	mean of Interleukin-6	after 6 months from the start of intervention
composition of the intestinal microbiota (metagenomics characteristics)	evaluation of gut microbiota structure by shotgun analysis	after 6 months from the start of intervention

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 29ES20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No