Clinical trial NCT03463967: Effects of Tomato Products in Children With NAFLD
Official title: Controlled Trial on the Effect of Tomato Products in Obese Children With Non Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NAFLD
Keywords: nonalcoholic steatohepatitis
obesity
dyslipidemia
diet
children
adolescents
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 61
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction of liver steatosis
timeFrame: Baseline and 16 weeks
measure: Reduction in BMI
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Reduction in ALT serum level
timeFrame: Baseline and 16 weeks
measure: Improvement of inflammatory state
timeFrame: Baseline and 16 weeks
measure: Amelioration of oxidative state
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Unit of Hepatology-Dept. of Pediatric Clinic
Study officials:
affiliation: University Federico II of Naples
name: Raffaele Iorio
role: PRINCIPAL_INVESTIGATOR
References: