Effects of Butyrate Against Pediatric Obesity (BAPO)
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
butyrate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Childhood
Eligibility Criteria
Inclusion Criteria:
- Children/adolescents with diagnosis of obesity (BMI >95° percentile for age and sex) observed at Pediatric Section of Department of Translational Medical Sciences (University of Naples Federico II)
Exclusion Criteria
- Age at enrollment <5 or >17 years
- BMI <95° percentile for age and sex
- Patients under pharmacological treatment for obesity (metformin)
- Patients assuming vitamin E,
- Patients assuming 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
Sites / Locations
- University of Naples Federico II
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Butyrate + standard care for pediatric obesity
placebo + standard care for pediatric obesity
Arm Description
standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day)
standard care for pediatric obesity + placebo (cornstarch)
Outcomes
Primary Outcome Measures
BMI z-score change
BMI z-score change at least of ≥ 0.25
Secondary Outcome Measures
waist circumference
mean waist circumference change
HOMA index change
mean of HOMA index change
fasting glucose change
mean of fasting glucose change
fasting insulin change
mean of fasting insulin change
total cholesterol change
mean of total cholesterol change
Low density Lipoprotein cholesterol change
mean of Low density Lipoprotein cholesterol change
High density Lipoprotein cholesterol change
mean of high density Lipoprotein cholesterol change
plasma triglycerides change
mean of plasma triglycerides change
micro RNA 221- expression
mean of mir221- expression
serum ghrelin
mean of serum ghrelin
serum Interleukin-6
mean of Interleukin-6
composition of the intestinal microbiota (metagenomics characteristics)
evaluation of gut microbiota structure by shotgun analysis
Full Information
NCT ID
NCT04620057
First Posted
October 26, 2020
Last Updated
March 31, 2022
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT04620057
Brief Title
Effects of Butyrate Against Pediatric Obesity
Acronym
BAPO
Official Title
Effects of Oral Supplementation of Butyrate in Children With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Worldwide obesity is a public health concern that is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. The main drivers of obesity pathogenesis seem to be a long-term of energy discrepancy between too many calories consumed and an increase of sedentary behavior. A growing body of evidence suggests that the set of microbes that live within the digestive tract, making up the gut microbiota (GM), play a metabolic role in energy regulation and substrate metabolism. Various factors can impact GM, one of these are dietary compounds that deeply affect the growth and metabolism of gut bacteria, since fermentation of nutrients is one core function of the intestinal microbes. Among fermentation products an array of small organic metabolites are short-chain fatty acids (SCFAs) acetate, propionate and butyrate. Among SCFAs, the C-4 fatty acid butyrate, the main fuel for the colonocytes, might have a potential in alleviating obesity and related metabolic complications. Butyrate could act as a regulator of body weight: a reasonable speculation is that butyrate acts on components of the energy balance, promoting energy expenditure and/or reducing energy intake. Preclinical studies have shown that butyrate supplementation prevent high-fat diet-induced obesity and it is able to treat obesity. With the sharp increase of obesity prevalence seen in the pediatric population, novel insights are necessary to counteract this epidemic disease, the outcome of the study is to see whether oral butyrate supplementation could exert similar effect in obese children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Butyrate + standard care for pediatric obesity
Arm Type
Experimental
Arm Description
standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day)
Arm Title
placebo + standard care for pediatric obesity
Arm Type
Placebo Comparator
Arm Description
standard care for pediatric obesity + placebo (cornstarch)
Intervention Type
Dietary Supplement
Intervention Name(s)
butyrate
Intervention Description
sodium butyrate (20 mg/kg body weight/day)
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
cornstarch
Primary Outcome Measure Information:
Title
BMI z-score change
Description
BMI z-score change at least of ≥ 0.25
Time Frame
after 6 months from the start of intervention
Secondary Outcome Measure Information:
Title
waist circumference
Description
mean waist circumference change
Time Frame
after 6 months from the start of intervention
Title
HOMA index change
Description
mean of HOMA index change
Time Frame
after 6 months from the start of intervention
Title
fasting glucose change
Description
mean of fasting glucose change
Time Frame
after 6 months from the start of intervention
Title
fasting insulin change
Description
mean of fasting insulin change
Time Frame
after 6 months from the start of intervention
Title
total cholesterol change
Description
mean of total cholesterol change
Time Frame
after 6 months from the start of intervention
Title
Low density Lipoprotein cholesterol change
Description
mean of Low density Lipoprotein cholesterol change
Time Frame
after 6 months from the start of intervention
Title
High density Lipoprotein cholesterol change
Description
mean of high density Lipoprotein cholesterol change
Time Frame
after 6 months from the start of intervention
Title
plasma triglycerides change
Description
mean of plasma triglycerides change
Time Frame
after 6 months from the start of intervention
Title
micro RNA 221- expression
Description
mean of mir221- expression
Time Frame
after 6 months from the start of intervention
Title
serum ghrelin
Description
mean of serum ghrelin
Time Frame
after 6 months from the start of intervention
Title
serum Interleukin-6
Description
mean of Interleukin-6
Time Frame
after 6 months from the start of intervention
Title
composition of the intestinal microbiota (metagenomics characteristics)
Description
evaluation of gut microbiota structure by shotgun analysis
Time Frame
after 6 months from the start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children/adolescents with diagnosis of obesity (BMI >95° percentile for age and sex) observed at Pediatric Section of Department of Translational Medical Sciences (University of Naples Federico II)
Exclusion Criteria
Age at enrollment <5 or >17 years
BMI <95° percentile for age and sex
Patients under pharmacological treatment for obesity (metformin)
Patients assuming vitamin E,
Patients assuming 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
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Butyrate Against Pediatric Obesity
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