The Effects of Butyrate on Children With Obesity
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|ClinicalTrials.gov Identifier: NCT02721953|
Recruitment Status : Unknown
Verified March 2016 by Roberto Berni Canani, Federico II University.
Recruitment status was: Recruiting
First Posted : March 29, 2016
Last Update Posted : March 30, 2016
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effects of Butyrate on Insulin Resistance in Children Affected by Obesity|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: Hypocaloric diet plus butyrate
Hypocaloric diet plus butyrate
Dietary Supplement: Butyrate
Placebo Comparator: Hypocaloric diet plus placebo
Hypocaloric diet plus placebo
- Reduction of insulin resistance [ Time Frame: After 6 months of treatment ]
- Reduction of body weight [ Time Frame: After 6 months of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721953
|University of Naples Federico II||Recruiting|
|Naples, Italy, 80131|
|Contact: Roberto Berni Canani, MD, PhD +390817462680|