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The Effects of Butyrate on Children With Obesity

NCT02721953 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-30

No results posted yet for this study

Summary

Butyrate is a short chain fatty acid (SCFA) produced by bacterial fermentation of undigested starch in the gut. Butyrate carries out different effects at intestinal and extraintestinal level, including: immune regulation with anti-inflammatory effect at intestinal and systemic level and modulation of gut microbiota. Many of these effects result from an epigenetic mechanism. Shown in an animal model of obesity induced by a high fat diet (HFD), that butyrate can exercise very effective protective action against obesity through the stimulation of intestinal satiety hormones. Shown always in murine model of obesity induced by HFD, that butyrate is effective in preventing and treating obesity and insulin resistance. After 5 weeks of treatment with butyrate was observed a reduction of 10.2% of body weight, 30% of fasting glucose and 50% insulin resistance.

In an animal model of metabolic syndrome with NAFLD researchers have recently demonstrated that the administration of butyrate is able to significantly reduce insulin resistance, liver damage, dyslipidaemia through a modulation of the inflammatory process.

Pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of butyrate is safe and well tolerated. The peak serum levels occurs 4-6 hours after oral administration.

All of these data makes plausible a possible positive effect on insulin resistance in the obese child.

Conditions

Interventions

DIETARY_SUPPLEMENT

Butyrate

Butyrate

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-01-31
Completion
2018-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02721953 on ClinicalTrials.gov