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

NCT06389851 | Completed

• 1 other identifier: NAFLD-LYCOPENE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NAFLD; Liver Diseases; IBS

Outcome Measures

Primary Outcomes (5)

• The effect of intervention on CAP value (Controlled Attenuation Parameter)

  To evaluate whether the adoption of a diet enriched with tomato and sauce in patients suffering from NAFLD can exert favorable effects, after 6 weeks of treatment, on the CAP value (Controlled Attenuation Parameter), a parameter which evaluates the level of Liver Fibrosis, measured by Fibroscan.

  at Baseline and after 6 days weeks

• The effect of intervention on FLI value (fatty liver index)

  To evaluate whether the adoption of a diet enriched with tomato and sauce in patients with NAFLD can exert favorable effects on the FLI value (fatty liver index), based on anthropometric parameters (BMI, abdominal circumference) and blood chemistry (triglycerides and γGT)

  at Baseline and after 6 days weeks

• The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis

  To evaluate whether the adoption of a diet enriched with tomato and sauce in patients with NAFLD affects routine blood chemistry parameters. The following will be taken into consideration: Blood sugar, Glycated hemoglobin, triglycerides, total cholesterol

  at Baseline and after 6 days weeks

• The effect of the intervention on the integrity of the intestinal barrier

  To evaluate whether the adoption of a diet enriched with tomato and sauce in patients with NAFLD affects the integrity of the intestinal barrier and the microbiota

  at Baseline and after 6 days weeks

• The effect of the intervention on the microbiota

  To evaluate whether the adoption of a diet enriched with tomato and sauce in patients with NAFLD affects the microbiota

  at Baseline and after 6 days weeks

Study Arms (2)

Case Group - Tomato-free diet

EXPERIMENTAL

Subjects assigned to this arm will follow a tomato-free diet

Dietary Supplement: Experimental: Case Group - Tomato-free diet

Case group - Diet enriched with tomatoes

EXPERIMENTAL

Subjects assigned to this group will follow a diet with pre-established quantities of tomato and sauce

Dietary Supplement: Experimental: Case group - Diet enriched with tomatoes

Interventions

Experimental: Case Group - Tomato-free diet DIETARY_SUPPLEMENT

Nutritional intervention without tomatoes and sauce

Also known as: Tomato-free diet

Case Group - Tomato-free diet

Experimental: Case group - Diet enriched with tomatoes DIETARY_SUPPLEMENT

Nutritional intervention enriched with tomatoes and souce

Also known as: Diet enriched with tomatoes

Case group - Diet enriched with tomatoes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with BMI≤30;
• Diagnosis of hepatic steatosis, formulated on the basis of criteria

You may not qualify if:

• Patients with BMI \> 30;
• Pregnancy or breastfeeding;
• Serious medical conditions that may compromise participation in the trial;
• People following a special diet.

Sponsors & Collaborators

• Dr. Di Stasi Vincenza: collaborator
• Dr. Donvito Rosanna: collaborator
• Dr. Cozzolongo Raffaele: collaborator
• Dr. Giannuzzi Vito: collaborator
• Dr. Zappimbulso Marianna: collaborator
• Dr. Shahini Endrit: collaborator
• Dr. Notarnicola Maria: collaborator
• Dr. Russo Francesco: collaborator
• Dr. Riezzo Giuseppe: collaborator
• Dr. Donghia Rossella: collaborator
• Dr. Cesternino Anna Maria: collaborator
• Dr. Cici Rosalisa: collaborator
• Dr. Cerabino Nicole: collaborator
• Dr. Martina Di Chito: collaborator
• Dr. Pesole Pasqua Letizia: collaborator
• Dr. Coletta Sergio: collaborator
• Dr. Stabile Dolores: collaborator
• Dr. Ancona Anna: collaborator
• Dr. D'Attoma Benedetta: collaborator
• Dr. Ignazzi Antonia: collaborator
• Dr. De Nunzio Valentina: collaborator
• Dr. Tatoli Rossella: collaborator
• Dr. Pinto Giuliano: collaborator
• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

Irccs Saverio de Bellis

Castellana Grotte, BARI, 70013, Italy

Location

Related Publications (4)

• Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023 Apr 1;77(4):1335-1347. doi: 10.1097/HEP.0000000000000004. Epub 2023 Jan 3.

  PMID: 36626630 BACKGROUND

• Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.

  PMID: 28930295 BACKGROUND

• Saini RK, A Bekhit AE, Roohinejad S, Rengasamy KRR, Keum YS. Chemical Stability of Lycopene in Processed Products: A Review of the Effects of Processing Methods and Modern Preservation Strategies. J Agric Food Chem. 2020 Jan 22;68(3):712-726. doi: 10.1021/acs.jafc.9b06669. Epub 2020 Jan 7.

  PMID: 31891495 BACKGROUND

• Wu S, Yuan C, Yang Z, Liu S, Zhang Q, Zhang S, Zhu S. Non-alcoholic fatty liver is associated with increased risk of irritable bowel syndrome: a prospective cohort study. BMC Med. 2022 Aug 22;20(1):262. doi: 10.1186/s12916-022-02460-8.

  PMID: 35989356 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The study evaluates the effects on NAFLD, Intestinal Integrity and Microbiota of a diet enriched with tomatoes compared to a diet without tomatoes

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 29, 2024
• Study Start: May 14, 2024
• Primary Completion: May 20, 2025
• Study Completion: January 20, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)