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Clinical Trials/NCT06398522
NCT06398522CompletedNot Applicable

Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome: a Randomized Double-blind Placebo-controlled Clinical Trial

University of Bologna2 sites in 1 country50 target enrollmentStarted: March 1, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Effect on Fatty Liver Index
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •40-75 years of age
  • •Caucasian ethnicity
  • •Metabolic Syndrome

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Effect on Hepatic Steatosis Index(3 months)
  • Effect on Lipid Accumulation Product(3 months)

Investigators

Sponsor
University of Bologna
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudio Borghi

Prof. Dr.

University of Bologna

Study Sites (2)

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