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

University of Bologna50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

NAFLD Metabolic Syndrome

Interventions

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Bologna

Bologna, BO, Italy

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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

Time frame: 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

Time frame: 3 months

Data from ClinicalTrials.gov

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