Effects of Butyrate Against Pediatric Obesity

Obesity, Childhood Clinical Trial

— BAPO  

Official title:

Effects of Oral Supplementation of Butyrate in Children With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04620057
• Other study ID #: 29ES20
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Dietary Supplement:
• butyrate
sodium butyrate (20 mg/kg body weight/day)

Other:
• placebo
cornstarch

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score change	BMI z-score change at least of = 0.25	after 6 months from the start of intervention
Secondary	waist circumference	mean waist circumference change	after 6 months from the start of intervention
Secondary	HOMA index change	mean of HOMA index change	after 6 months from the start of intervention
Secondary	fasting glucose change	mean of fasting glucose change	after 6 months from the start of intervention
Secondary	fasting insulin change	mean of fasting insulin change	after 6 months from the start of intervention
Secondary	total cholesterol change	mean of total cholesterol change	after 6 months from the start of intervention
Secondary	Low density Lipoprotein cholesterol change	mean of Low density Lipoprotein cholesterol change	after 6 months from the start of intervention
Secondary	High density Lipoprotein cholesterol change	mean of high density Lipoprotein cholesterol change	after 6 months from the start of intervention
Secondary	plasma triglycerides change	mean of plasma triglycerides change	after 6 months from the start of intervention
Secondary	micro RNA 221- expression	mean of mir221- expression	after 6 months from the start of intervention
Secondary	serum ghrelin	mean of serum ghrelin	after 6 months from the start of intervention
Secondary	serum Interleukin-6	mean of Interleukin-6	after 6 months from the start of intervention
Secondary	composition of the intestinal microbiota (metagenomics characteristics)	evaluation of gut microbiota structure by shotgun analysis	after 6 months from the start of intervention