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Effects of Butyrate Against Pediatric Obesity (BAPO)

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: NCT04620057
Recruitment Status : Completed
First Posted : November 6, 2020
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, MD, PhD, Federico II University

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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Dietary Supplement: butyrate Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Oral Supplementation of Butyrate in Children With Obesity
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Butyrate + standard care for pediatric obesity
standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day)
Dietary Supplement: butyrate
sodium butyrate (20 mg/kg body weight/day)

Placebo Comparator: placebo + standard care for pediatric obesity
standard care for pediatric obesity + placebo (cornstarch)
Other: placebo
cornstarch




Primary Outcome Measures :
  1. BMI z-score change [ Time Frame: after 6 months from the start of intervention ]
    BMI z-score change at least of ≥ 0.25


Secondary Outcome Measures :
  1. waist circumference [ Time Frame: after 6 months from the start of intervention ]
    mean waist circumference change

  2. HOMA index change [ Time Frame: after 6 months from the start of intervention ]
    mean of HOMA index change

  3. fasting glucose change [ Time Frame: after 6 months from the start of intervention ]
    mean of fasting glucose change

  4. fasting insulin change [ Time Frame: after 6 months from the start of intervention ]
    mean of fasting insulin change

  5. total cholesterol change [ Time Frame: after 6 months from the start of intervention ]
    mean of total cholesterol change

  6. Low density Lipoprotein cholesterol change [ Time Frame: after 6 months from the start of intervention ]
    mean of Low density Lipoprotein cholesterol change

  7. High density Lipoprotein cholesterol change [ Time Frame: after 6 months from the start of intervention ]
    mean of high density Lipoprotein cholesterol change

  8. plasma triglycerides change [ Time Frame: after 6 months from the start of intervention ]
    mean of plasma triglycerides change

  9. micro RNA 221- expression [ Time Frame: after 6 months from the start of intervention ]
    mean of mir221- expression

  10. serum ghrelin [ Time Frame: after 6 months from the start of intervention ]
    mean of serum ghrelin

  11. serum Interleukin-6 [ Time Frame: after 6 months from the start of intervention ]
    mean of Interleukin-6

  12. composition of the intestinal microbiota (metagenomics characteristics) [ Time Frame: after 6 months from the start of intervention ]
    evaluation of gut microbiota structure by shotgun analysis



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04620057


Locations
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Italy
University of Naples Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
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Responsible Party: Roberto Berni Canani, MD, PhD, Chief of the Pediatric Allergy Program at the Department of Translational Medical Science Chief of the ImmunoNutritionLab at CEINGE - Advanced Biotechnologies, Federico II University
ClinicalTrials.gov Identifier: NCT04620057    
Other Study ID Numbers: 29ES20
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight