Effects of tomato consumption on liver health and gut function in patients with fatty liver disease
Evaluation of the Effects of Tomato Consumption on the Parameters of Hepatic Steatosis, Intestinal Function and on Glucose and Lipid Metabolism in Subjects With NAFLD
This study tests if eating more tomatoes can improve liver health and gut function in people with fatty liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Academic / other |
| Locations | 1 site (Castellana Grotte, Bari) |
| Trial ID | NCT06389851 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the impact of a diet enriched with tomatoes on various health aspects in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). The study aims to assess changes in hepatic steatosis, inflammation levels, metabolic risk factors, intestinal barrier function, body composition, gut microbiota, and symptoms of irritable bowel syndrome (IBS). Participants will be divided into two groups: one following a tomato-free diet and the other consuming a diet enriched with tomatoes. The outcomes will help determine the potential benefits of tomato consumption on liver and gut health.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a BMI of 30 or less who have been diagnosed with hepatic steatosis.
Not a fit: Patients with a BMI greater than 30 or those with other medical conditions affecting steatosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve liver health and reduce symptoms of IBS in patients with NAFLD.
How similar studies have performed: While dietary interventions for liver health have been explored, this specific approach using tomato consumption is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with BMI≤30; * Diagnosis of hepatic steatosis, formulated on the basis of criteria Exclusion Criteria: * Patients with BMI \> 30; * Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria; * Pregnancy or breastfeeding; * Serious medical conditions that may compromise participation in the trial; * People following a special diet.
Where this trial is running
Castellana Grotte, Bari
- Irccs Saverio de Bellis — Castellana Grotte, Bari, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni De Pergola, MD
- Email: giovanni.depergola@irccsdebellis.it
- Phone: 0804994653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.