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Completed

NCT Number: NCT06398522

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

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

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bologna

Bologna, BO, 40138, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3

Dietary Supplement

Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3

Placebo

Other

Placebo

Primary outcomes

  1. 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

  1. Effect on Hepatic Steatosis Index

    Time frame: 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

  2. Effect on Lipid Accumulation Product

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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