NCT02721953

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

March 23, 2016

Last Update Submit

March 29, 2016

Conditions

Insulin ResistanceObesity

Outcome Measures

Primary Outcomes (1)

  • Reduction of insulin resistance

    After 6 months of treatment

Secondary Outcomes (1)

  • Reduction of body weight

    After 6 months of treatment

Study Arms (2)

Hypocaloric diet plus butyrate

EXPERIMENTAL

Hypocaloric diet plus butyrate

Dietary Supplement: Butyrate

Hypocaloric diet plus placebo

PLACEBO COMPARATOR

Hypocaloric diet plus placebo

Other: Placebo

Interventions

ButyrateDIETARY_SUPPLEMENT

Butyrate

Hypocaloric diet plus butyrate
PlaceboOTHER

Placebo

Hypocaloric diet plus placebo

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Insulin ResistanceObesity

Interventions

Butyrates

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 29, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

March 30, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)