NAFLDNCT06398522
Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome
A study testing Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3 in people with NAFLD and Metabolic Syndrome, run by University of Bologna at 1 site in Italy.
Trial summary
This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effect of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 on liver steatosis in individuals with NAFLD and metabolic syndrome Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Metabolic Syndrome
- What is being tested?
- Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 1 Jun 2018
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-75 years of age
- Caucasian ethnicity
- NAFLD
- Metabolic Syndrome
Who cannot join
- acute and chronic gastrointestinal disorder not controlled by stable treatment since at least 3 months
- serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
- obesity (body mass index (BMI)> 30 Kg/m2)
- type 1 and 2 diabetes
- alcoholism
- pregnancy and breastfeeding
- any medical or surgical condition making complex or inconstant the adhesion to the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome: a Randomized Double-blind Placebo-controlled Clinical Trial
This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effect of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 on liver steatosis in individuals with NAFLD and metabolic syndrome
- Conditions
- NAFLD, Metabolic Syndrome
- Being tested
- Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3Dietary supplement
Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Food for special medical purposes | Active comparator | Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 Receives: Dietary Supplement: Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on Fatty Liver Index
We evaluated the effect on Fatty Liver Index (FLI) of 3-month assumption of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3, compared to either baseline and placebo
Measured: 3 months
Secondary outcomes (2)
Effect on Hepatic Steatosis Index
We evaluated the effect on Hepatic Steatosis Index (HSI) of 3-month assumption of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3, compared to either baseline and placebo
Measured: 3 months
Effect on Lipid Accumulation Product
We evaluated the effect on Lipid Accumulation Product (LAP) of 3-month assumption of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3, compared to either baseline and placebo
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Mar 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
- Investigators
- Claudio Borghi, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398522
- Sponsor's protocol ID
- But_17
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome: a Randomized Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06398522
- Acronym / sponsor ID
- But_17
- Conditions
- NAFLD, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 3 May 2024 (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.
This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effect of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 on liver steatosis in individuals with NAFLD and metabolic syndrome
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 |
|---|---|---|
| Food for special medical purposes | Active comparator | Dietary Supplement: Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40-75 years of age
- Caucasian ethnicity
- NAFLD
- Metabolic Syndrome
Key exclusion criteria (7 listed)
- acute and chronic gastrointestinal disorder not controlled by stable treatment since at least 3 months
- serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
- obesity (body mass index (BMI)> 30 Kg/m2)
- type 1 and 2 diabetes
- alcoholism
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 |
|---|---|---|
| Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 | Dietary supplement | Food for special medical purposes |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Effect on Fatty Liver Index
Time frame: 3 months
We evaluated the effect on Fatty Liver Index (FLI) of 3-month assumption of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3, compared to either baseline and placebo
2 secondary outcomes
Effect on Hepatic Steatosis Index
Time frame: 3 months
Effect on Lipid Accumulation Product
Time frame: 3 months
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 3 May 2024.
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RecruitingPhase 1
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A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
Claudio Borghi principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3 in people with NAFLD and Metabolic Syndrome, run by University of Bologna 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 4 inclusion and 7 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 3 May 2024. 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?
Effect on Fatty Liver Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2024.