Effects of Tomato Products in Children With NAFLD

March 12, 2018 updated by: Prof. Raffaele Iorio, Federico II University

Controlled Trial on the Effect of Tomato Products in Obese Children With Non Alcoholic Fatty Liver Disease

CONTROLLED TRIAL ON THE EFFECT OF TOMATO PRODUCTS IN OBESE CHILDREN WITH NON ALCOHOLIC FATTY LIVER DISEASE

Aim of the study To evaluate the effect of the addition of a daily dose of lycopene enriched tomato sauce on the progress of NAFDL in obese children.

Participants Children with obesity referred to the Hepatology unit of Dept.of Pediatric Clinic of the University Federico II of Naples. Diagnosis of NAFLD is made on the presence of fatty liver at ultrasound examination, with or without hypertransaminasemia.

Patients are eligible on the basis of:

  • Age 4-14 years
  • BMI > 85°percentile
  • Liver Steatosis evaluated as mild, moderate or severe by US (hyperechogenic liver tissue compared with the adjacent kidney cortex)

Patients are excluded on the basis of:

  • Liver disease
  • Diabetes or manifest metabolic alterations
  • Associated diseases Informed consent is obtained from the parents of the participating children. Sample size estimation To provide an 80% power to detect a 25% or greater relative shift of outcome variables, with a first degree error of .05 a sample of 50 cases is estimated in a cross over trial.

Study design This is a randomized, crossover, one side open trial with blinded outcome evaluation. A statistician who is not otherwise involved in the trial generated the randomized assignment sequence. At the enrollment all participants received a low carotenoids diet for two weeks (wash out), then children are assigned to the first intervention for 8 weeks, and subsequently, in the crossover phase, they are switched to the second intervention for the next 8 weeks. No wash out is planned between the two treatments.

Interventions

  1. Supplemented diet: 100 gr/day of Lycopene enriched tomato products (weekly average)
  2. Control diet: ordinary healthy diet, with no special encouragement to eat carotenes products All children are put on a 'mediterranean style' diet, with a controlled amount of calories: a dedicated dietitian for the whole study, irrespective of the treatment, checked their diet twice a week.

At beginning (T0) and at the end of each treatment (T1 and T2) all patients underwent anthropomorphic measurements, including weight, height, waist, abdomen and hips circumferences. BMI and its standard deviation score are calculated.

Regardless of group assignment, all participants are seen by a hepatologist at the end of each intervention and checked for liver steatosis, by US. Fasting blood samples are collected at beginning (T0) and at the end of each treatment (T1 and T2) to evaluate IR (assessed by HOMA), transaminases levels, lipids profile, oxidative state (assessed by antioxidant enzymes activity, serum levels of MDA and carbonylated proteins), inflammatory state (by cytokines serum levels, typing of lymphocytes subpopulations, metabolism of lymphocytes).

Data collection are performed in a partially blind fashion: the statistician performing data analysis is blind to treatment.

Outcomes: The primary outcome is reduction of the liver steatosis estimated by US Scan, according to the following parameters: parenchyma echogenicity (compared with that of the cortical of the right kidney), far gain attenuation, diaphragm blurring. steatosis.

Secondary outcomes is reduction in Insulin resistance, Oxidative state, Inflammatory state.

Statistical Analysis Data are inspected for normality and paired t-test (before/after) of each phase of the trial are performed when appropriate. The Median % change of each variable between the values at Time 8 and 16 weeks and values at enrollment are also looked. Ordinal logistic regression analysis, hierarchical, mixed model with adjustment variables are adopted to estimate the size of the effect.

The study is approved by the Ethical Committee of University Federico II of Naples.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Raffaele Iorio, Professor
  • Phone Number: 0039 081 7464337
  • Email: riorio@unina.it

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • Unit of Hepatology-Dept. of Pediatric Clinic
        • Contact:
          • Raffaele Iorio, Professor
          • Phone Number: 0039 081 7464337
          • Email: riorio@unina.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 4-14 years
  • BMI > 85°percentile
  • Liver Steatosis evaluated as mild, moderate or severe by US (hyperechogenic liver tissue compared with the adjacent kidney cortex)

Exclusion Criteria:

  • Liver diseases
  • Diabetes or manifest metabolic alterations
  • Associated diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lycopene supplemented
Energy-restricted diet supplemented with lycopene-enriched tomato juice
Dietary supplement: Lycopene-enriched tomato juice
Energy-restricted diet supplemented with Lycopene-enriched tomato juice
Other Names:
  • TOMATO
Other: Energy-restricted diet
Other Names:
  • DIET
Sham Comparator: Calories Restricted
Energy-restricted diet
Dietary supplement: Lycopene-enriched tomato juice
Energy-restricted diet supplemented with Lycopene-enriched tomato juice
Other Names:
  • TOMATO
Other: Energy-restricted diet
Other Names:
  • DIET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of liver steatosis
Time Frame: Baseline and 16 weeks

The presence and severity of liver steatosis are graded by using the following criteria:

2. The presence of hyperechogenic liver tissue (compared with the adjacent kidney cortex) with fine and tightly packed echo targets and of normal beam penetration with normal visualization of diaphragm and portal vein borders is considered as mild steatosis.

3. The moderate and diffuse increase of echo intensity with decreased beam penetration (with slightly decreased visualization of diaphragm) associated with a decrease in visualization of silhouetting of the portal vein borders is considered as moderate steatosis.

4. The marked increase in echoes intensity with no visualization of portal vein border, obscured diaphragm and posterior portion of the right lobe, and reduced visibility of kidney is considered as severe steatosis.
Baseline and 16 weeks
Reduction in BMI
Time Frame: Baseline and 16 weeks
Standard methods of evaluation
Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in ALT serum level
Time Frame: Baseline and 16 weeks
Standard method of evaluation
Baseline and 16 weeks
Improvement of inflammatory state
Time Frame: Baseline and 16 weeks
Evaluation of serum levels of standard markers of inflammation (CRP, ferritin); cytokines profiling, lymphocyte typing
Baseline and 16 weeks
Amelioration of oxidative state
Time Frame: Baseline and 16 weeks
Evaluation of activity of serum antioxidant enzymes and markers of oxidative stress (MDA, Carbonylate proteins, oxidized LDL)
Baseline and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Raffaele Iorio, University Federico II of Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD1016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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