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OpenTrials
Completed

NCT Number: NCT04620057

Effects of Butyrate Against Pediatric Obesity

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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butyrate

Dietary Supplement

sodium butyrate (20 mg/kg body weight/day)

Placebo

Other

cornstarch

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Effects of Oral Supplementation of Butyrate in Children With Obesity

Acronym: BAPO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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