Obesity, ChildhoodBAPONCT04620057
Effects of Butyrate Against Pediatric Obesity
A study testing butyrate in people with Obesity, Childhood, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- butyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Supplementation of Butyrate in Children With 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.
- Conditions
- Obesity, Childhood
- Being tested
- butyrate, placebo
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
butyrateDietary supplement
sodium butyrate (20 mg/kg body weight/day)
placeboOther
cornstarch
| Study group | Role | What they receive |
|---|---|---|
| Butyrate + standard care for pediatric obesity | Experimental | standard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day) Receives: Dietary Supplement: butyrate |
| placebo + standard care for pediatric obesity | Placebo comparator | standard care for pediatric obesity + placebo (cornstarch) Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score change
BMI z-score change at least of ≥ 0.25
Measured: after 6 months from the start of intervention
Secondary outcomes (12)
waist circumference
mean waist circumference change
Measured: after 6 months from the start of intervention
HOMA index change
mean of HOMA index change
Measured: after 6 months from the start of intervention
fasting glucose change
mean of fasting glucose change
Measured: after 6 months from the start of intervention
fasting insulin change
mean of fasting insulin change
Measured: after 6 months from the start of intervention
total cholesterol change
mean of total cholesterol change
Measured: after 6 months from the start of intervention
Low density Lipoprotein cholesterol change
mean of Low density Lipoprotein cholesterol change
Measured: after 6 months from the start of intervention
High density Lipoprotein cholesterol change
mean of high density Lipoprotein cholesterol change
Measured: after 6 months from the start of intervention
plasma triglycerides change
mean of plasma triglycerides change
Measured: after 6 months from the start of intervention
micro RNA 221- expression
mean of mir221- expression
Measured: after 6 months from the start of intervention
serum ghrelin
mean of serum ghrelin
Measured: after 6 months from the start of intervention
serum Interleukin-6
mean of Interleukin-6
Measured: after 6 months from the start of intervention
composition of the intestinal microbiota (metagenomics characteristics)
evaluation of gut microbiota structure by shotgun analysis
Measured: after 6 months from the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620057
- Sponsor's protocol ID
- 29ES20
- Acronym
- BAPO
- Status last verified
- Mar 2022
- First submitted
- 26 Oct 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coppola S, Nocerino R, Paparo L, Bedogni G, Calignano A, Di Scala C, de Giovanni di Santa Severina AF, De Filippis F, Ercolini D, Berni Canani R. Therapeutic Effects of Butyrate on Pediatric Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244912. doi: 10.1001/jamanetworkopen.2022.44912.
PubMed 36469320
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Supplementation of Butyrate in Children With Obesity
- ClinicalTrials.gov ID
- NCT04620057
- Acronym / sponsor ID
- BAPO / 29ES20
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butyrate + standard care for pediatric obesity | Experimental | Dietary Supplement: butyratestandard care for pediatric obesity + sodium butyrate (20 mg/kg body weight/day) |
| placebo + standard care for pediatric obesity | Placebo comparator | Other: placebostandard care for pediatric obesity + placebo (cornstarch) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| butyratesodium butyrate (20 mg/kg body weight/day) | Dietary supplement | Butyrate + standard care for pediatric obesity |
| placebocornstarch | Other | placebo + standard care for pediatric obesity |
Primary outcome
BMI z-score change
Time frame: after 6 months from the start of intervention
BMI z-score change at least of ≥ 0.25
12 secondary outcomes
waist circumference
Time frame: after 6 months from the start of intervention
HOMA index change
Time frame: after 6 months from the start of intervention
fasting glucose change
Time frame: after 6 months from the start of intervention
fasting insulin change
Time frame: after 6 months from the start of intervention
total cholesterol change
Time frame: after 6 months from the start of intervention
Low density Lipoprotein cholesterol change
Time frame: after 6 months from the start of intervention
High density Lipoprotein cholesterol change
Time frame: after 6 months from the start of intervention
plasma triglycerides change
Time frame: after 6 months from the start of intervention
micro RNA 221- expression
Time frame: after 6 months from the start of intervention
serum ghrelin
Time frame: after 6 months from the start of intervention
serum Interleukin-6
Time frame: after 6 months from the start of intervention
composition of the intestinal microbiota (metagenomics characteristics)
Time frame: after 6 months from the start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 36469320Coppola S, Nocerino R, Paparo L, Bedogni G, Calignano A, Di Scala C, de Giovanni di Santa Severina AF, De Filippis F, Ercolini D, Berni Canani R. Therapeutic Effects of Butyrate on Pediatric Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244912. doi: 10.1001/jamanetworkopen.2022.44912.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing butyrate in people with Obesity, Childhood, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score change (time frame: after 6 months from the start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.