Effects of Butyrate Against Pediatric Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Butyrate + standard care for pediatric obesity

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

Group Type EXPERIMENTAL

butyrate

Intervention Type DIETARY_SUPPLEMENT

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

placebo + standard care for pediatric obesity

standard care for pediatric obesity + placebo (cornstarch)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

cornstarch

Interventions

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butyrate

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

Intervention Type DIETARY_SUPPLEMENT

placebo

cornstarch

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Roberto Berni Canani, MD, PhD

Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies

Responsibility Role PRINCIPAL_INVESTIGATOR