Effects of Butyrate Against Pediatric Obesity

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Other: placebo; Dietary Supplement: butyrate

• Registration Number: NCT04620057
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study Start: 2020-11-01
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-06
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo + standard care for pediatric obesity	placebo	standard care for pediatric obesity + placebo (cornstarch)
Butyrate + standard care for pediatric obesity	butyrate	standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day)

Primary Outcome Measures

Name	Time	Method
BMI z-score change	after 6 months from the start of intervention	BMI z-score change at least of ≥ 0.25

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy