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NCT06398522 Clinical Trial

Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06398522
Other study ID # But_17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date June 1, 2018

Study information
Verified date May 2024
Source University of Bologna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion criteria: - 40-75 years of age - Caucasian ethnicity - NAFLD - 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3
Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3
Other:
• Placebo
Placebo

Locations
Country Name City State
Italy University of Bologna Bologna BO

Sponsors (1)
Lead Sponsor Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 3 months
Secondary 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 3 months
Secondary 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 3 months
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