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

Not Applicable

Completed

• Conditions: NAFLD; Metabolic Syndrome
• Interventions: Dietary Supplement: Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3; Other: Placebo

• Registration Number: NCT06398522
• Lead Sponsor: University of Bologna

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-01
• Last Update Submitted: 2024-05-01
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food for special medical purposes	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
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Effect on Fatty Liver Index	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 Outcome Measures

Name	Time	Method
Effect on Hepatic Steatosis Index	3 months	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
Effect on Lipid Accumulation Product	3 months	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

Trial Locations

Locations (1)

University of Bologna; 🇮🇹 Bologna, BO, Italy