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

University of Bologna

Status: Completed

Conditions: NAFLD; Metabolic Syndrome

Treatments: Other: Placebo; Dietary Supplement: Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT06398522

But_17

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Food for special medical purposes

Active Comparator group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Treatment:

Other: Placebo