The Effects of Butyrate on Children With Obesity

Obesity Clinical Trial

Official title:

Effects of Butyrate on Insulin Resistance in Children Affected by Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721953
• Other study ID #: 29/14
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 23, 2016
• Last updated: March 29, 2016
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• Butyrate
Butyrate

Other:
• Placebo
Placebo

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	Reduction of insulin resistance		After 6 months of treatment	No
Secondary	Reduction of body weight		After 6 months of treatment	No