Effects of Tomato Products in Children With NAFLD

NCT03463967 | Unknown

• 1 other identifier: TD1016
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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
• Supplemented diet: 100 gr/day of Lycopene enriched tomato products (weekly average)
• 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.

Conditions

NAFLD

Keywords

nonalcoholic steatohepatitis; obesity; dyslipidemia; diet; children; adolescents

Outcome Measures

Primary Outcomes (2)

• Reduction of liver steatosis

  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

  Standard methods of evaluation

  Baseline and 16 weeks

Secondary Outcomes (3)

• Reduction in ALT serum level

  Baseline and 16 weeks

• Improvement of inflammatory state

  Baseline and 16 weeks

• Amelioration of oxidative state

  Baseline and 16 weeks

Study Arms (2)

Lycopene supplemented

ACTIVE COMPARATOR

Energy-restricted diet supplemented with lycopene-enriched tomato juice

Dietary Supplement: Lycopene-enriched tomato juice; Other: Energy-restricted diet

Calories Restricted

SHAM COMPARATOR

Energy-restricted diet

Dietary Supplement: Lycopene-enriched tomato juice; Other: Energy-restricted diet

Interventions

Lycopene-enriched tomato juice DIETARY_SUPPLEMENT

Energy-restricted diet supplemented with Lycopene-enriched tomato juice

Also known as: TOMATO

Calories Restricted; Lycopene supplemented

Energy-restricted diet OTHER

Also known as: DIET

Calories Restricted; Lycopene supplemented

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Unit of Hepatology-Dept. of Pediatric Clinic

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Dyslipidemias

Interventions

Diet

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Raffaele Iorio

  University Federico II of Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Iorio, Professor

CONTACT

081 7464337; riorio@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Pediatric Hepathology Unit

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 13, 2018
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)