Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Tomato Products in Children With NAFLD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03463967
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Raffaele Iorio, Federico II University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
NAFLD Dietary Supplement: Lycopene-enriched tomato juice Other: Energy-restricted diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Controlled Trial on the Effect of Tomato Products in Obese Children With Non Alcoholic Fatty Liver Disease
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018


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 Name: TOMATO

Other: Energy-restricted diet
Other Name: DIET

Sham Comparator: Calories Restricted
Energy-restricted diet
Dietary Supplement: Lycopene-enriched tomato juice
Energy-restricted diet supplemented with Lycopene-enriched tomato juice
Other Name: TOMATO

Other: Energy-restricted diet
Other Name: DIET




Primary Outcome Measures :
  1. 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.


  2. Reduction in BMI [ Time Frame: Baseline and 16 weeks ]
    Standard methods of evaluation


Secondary Outcome Measures :
  1. Reduction in ALT serum level [ Time Frame: Baseline and 16 weeks ]
    Standard method of evaluation

  2. 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

  3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463967


Contacts
Layout table for location contacts
Contact: Raffaele Iorio, Professor 081 7464337 ext 0039 riorio@unina.it

Locations
Layout table for location information
Italy
Unit of Hepatology-Dept. of Pediatric Clinic Recruiting
Naples, Italy, 80131
Contact: Raffaele Iorio, Professor    081 7464337 ext 0039    riorio@unina.it   
Sponsors and Collaborators
Federico II University
Investigators
Layout table for investigator information
Principal Investigator: Raffaele Iorio University Federico II of Naples

Layout table for additonal information
Responsible Party: Prof. Raffaele Iorio, Chief of the Pediatric Hepathology Unit, Federico II University
ClinicalTrials.gov Identifier: NCT03463967     History of Changes
Other Study ID Numbers: TD1016
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Raffaele Iorio, Federico II University:
nonalcoholic steatohepatitis
obesity
dyslipidemia
diet
children
adolescents

Additional relevant MeSH terms:
Layout table for MeSH terms
Non-alcoholic Fatty Liver Disease
Fatty Liver
Liver Diseases
Digestive System Diseases
Lycopene
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents