NCT06398522

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

May 1, 2024

Last Update Submit

May 1, 2024

Conditions

NAFLDMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Effect on Hepatic Steatosis Index

    3 months

  • Effect on Lipid Accumulation Product

    3 months

Study Arms (2)

Food for special medical purposes

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3DIETARY_SUPPLEMENT

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

Food for special medical purposes
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Caucasian ethnicity
  • NAFLD
  • Metabolic Syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bologna

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Interventions

Foodgluconic acidCholecalciferol

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Claudio Borghi

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 3, 2024

Study Start

March 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

IT(1)