Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD

NCT06389851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-16

No results posted yet for this study

Summary

The study in question is an interventional study with nutritional intervention. the aim of the study is to evaluate whether a diet enriched with tomatoes can have favorable effects on:

* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
* intestinal barrier;
* body composition;
* intestinal microbiota;
* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD.

Conditions

  • NAFLD
  • IBS

Interventions

DIETARY_SUPPLEMENT

Experimental: Case Group - Tomato-free diet

Nutritional intervention without tomatoes and sauce

DIETARY_SUPPLEMENT

Experimental: Case group - Diet enriched with tomatoes

Nutritional intervention enriched with tomatoes and souce

Sponsors & Collaborators

  • Dr. Di Stasi Vincenza

    collaborator UNKNOWN
  • Dr. Donvito Rosanna

    collaborator UNKNOWN
  • Dr. Cozzolongo Raffaele

    collaborator UNKNOWN
  • Dr. Giannuzzi Vito

    collaborator UNKNOWN
  • Dr. Zappimbulso Marianna

    collaborator UNKNOWN
  • Dr. Shahini Endrit

    collaborator UNKNOWN
  • Dr. Notarnicola Maria

    collaborator UNKNOWN
  • Dr. Russo Francesco

    collaborator UNKNOWN
  • Dr. Riezzo Giuseppe

    collaborator UNKNOWN
  • Dr. Donghia Rossella

    collaborator UNKNOWN
  • Dr. Cesternino Anna Maria

    collaborator UNKNOWN
  • Dr. Cici Rosalisa

    collaborator UNKNOWN
  • Dr. Cerabino Nicole

    collaborator UNKNOWN
  • Dr. Martina Di Chito

    collaborator UNKNOWN
  • Dr. Pesole Pasqua Letizia

    collaborator UNKNOWN
  • Dr. Coletta Sergio

    collaborator UNKNOWN
  • Dr. Stabile Dolores

    collaborator UNKNOWN
  • Dr. Ancona Anna

    collaborator UNKNOWN
  • Dr. D'Attoma Benedetta

    collaborator UNKNOWN
  • Dr. Ignazzi Antonia

    collaborator UNKNOWN
  • Dr. De Nunzio Valentina

    collaborator UNKNOWN
  • Dr. Tatoli Rossella

    collaborator UNKNOWN
  • Dr. Pinto Giuliano

    collaborator UNKNOWN
  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2025-05-20
Completion
2026-01-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389851 on ClinicalTrials.gov