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

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; NAFLD
• Intervention / Treatment: Other: Placebo; Dietary supplement: Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • University of Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Active Comparator: Food for special medical purposes; Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Claudio Borghi, University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Liver Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Fatty Liver; Metabolic Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Calcium
• Other Study ID Numbers: But_17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No