Trials / Unknown
UnknownNCT02721953
The Effects of Butyrate on Children With Obesity
Effects of Butyrate on Insulin Resistance in Children Affected by Obesity
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Federico II University · Academic / Other
- Sex
- All
- Age
- 7 Years – 15 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Butyrate | Butyrate |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2018-01-01
- Completion
- 2018-03-01
- First posted
- 2016-03-29
- Last updated
- 2016-03-30
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02721953. Inclusion in this directory is not an endorsement.