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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06398522

Enrollment

Registered

2024-05-03

Start date

2017-03-01

Completion date

2018-06-01

Last updated

2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, NAFLD

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

Interventions

DIETARY_SUPPLEMENTFood 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

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026