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The Effects of Butyrate on Children With Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

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




Primary Outcome Measures :
  1. Reduction of insulin resistance [ Time Frame: After 6 months of treatment ]

Secondary Outcome Measures :
  1. Reduction of body weight [ Time Frame: After 6 months of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani, MD, PhD    +390817462680      
Sponsors and Collaborators
Federico II University
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Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02721953    
Other Study ID Numbers: 29/14
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases