Effects of Butyrate Against Pediatric Obesity

NCT04620057 | Completed

• 1 other identifier: 29ES20
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• BMI z-score change

  BMI z-score change at least of ≥ 0.25

  after 6 months from the start of intervention

Secondary Outcomes (12)

• waist circumference

  after 6 months from the start of intervention

• HOMA index change

  after 6 months from the start of intervention

• fasting glucose change

  after 6 months from the start of intervention

• fasting insulin change

  after 6 months from the start of intervention

• total cholesterol change

  after 6 months from the start of intervention

Study Arms (2)

Butyrate + standard care for pediatric obesity

EXPERIMENTAL

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

Dietary Supplement: butyrate

placebo + standard care for pediatric obesity

PLACEBO COMPARATOR

standard care for pediatric obesity + placebo (cornstarch)

Other: placebo

Interventions

butyrate DIETARY_SUPPLEMENT

sodium butyrate (20 mg/kg body weight/day)

Butyrate + standard care for pediatric obesity

placebo OTHER

cornstarch

placebo + standard care for pediatric obesity

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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,

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

• Coppola S, Nocerino R, Paparo L, Bedogni G, Calignano A, Di Scala C, de Giovanni di Santa Severina AF, De Filippis F, Ercolini D, Berni Canani R. Therapeutic Effects of Butyrate on Pediatric Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244912. doi: 10.1001/jamanetworkopen.2022.44912.

  PMID: 36469320 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Butyrates

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 6, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

IT (1)