The Effects of Butyrate on Children With Obesity

Sponsor

Federico II University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02721953

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Obesity	Dietary Supplement: Butyrate Other: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Butyrate on Insulin Resistance in Children Affected by Obesity

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypocaloric diet plus butyrate Hypocaloric diet plus butyrate	Dietary Supplement: Butyrate Butyrate
Placebo Comparator: Hypocaloric diet plus placebo Hypocaloric diet plus placebo	Other: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Hypocaloric diet plus butyrate

Hypocaloric diet plus butyrate

Dietary Supplement: Butyrate

Butyrate

Placebo Comparator: Hypocaloric diet plus placebo

Hypocaloric diet plus placebo

Other: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Reduction of insulin resistance [After 6 months of treatment]

Secondary Outcome Measures

Reduction of body weight [After 6 months of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Obesity (BMI >95° percentile)
HOmeostasis Model Assessment (HOMA-IR) > 4 (obtained by calculating the product of fasting plasma insulin expressed in microunits/mL and fasting plasma glucose expressed in mmol/L divided by 22.5)

Exclusion Criteria:

Age <10 or >15 years
BMI <95° centile
HOMA-IR <4
Patients under pharmacological treatment for obesity (metformin) or taking vitamin E, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Naples Federico II	Naples		Italy	80131

Sponsors and Collaborators

Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roberto Berni Canani, MD, PhD, Federico II University

ClinicalTrials.gov Identifier:

NCT02721953

Other Study ID Numbers:

29/14

First Posted:

Mar 29, 2016

Last Update Posted:

Mar 30, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Obesity

Insulin Resistance

Study Results

No Results Posted as of Mar 30, 2016