Metabolic Flexibility, Gut Microbiota, Healthy Diet and Exercise in NAFLD on Genetics Base

Summary

Nonalcoholic fatty liver disease (NAFLD) is associated to obesity, metabolic syndrome and genetic predisposition: specific variants of the genes PNPLA3 and TM6SF2 are the most involved. Also biochemical mechanisms that affect the "metabolic flexibility" need to be better clarified.

It is known that a dietary intervention, accompanied by a physical personalized training, reduce either the hepatic fat content either insulin resistance.

Therefore, the aim of the study is to evaluate "metabolic flexibility" in obese NAFLD subjects taking in account the presence or absence of PNPLA3 and TM6SF2 polymorphism and the histopathological diagnosis of either simple steatosis or nonalcoholic steatohepatitis (NASH). The composition of gut microbiota will be also evaluated.

Finally, two distinct healthy dietary profiles accompanied by a personalized physical training, will be tested to comprehend whether and how "healthy diets" could operate in the clinical treatment of NAFLD and related conditions.

Conditions

• Non-alcoholic Fatty Liver Disease
• Obesity

Interventions

DIETARY_SUPPLEMENT

Mediterranean diet

In the Mediterranean diet fat intake will be equal to 35% of the total energy intake minus carbohydrate and protein energy carbohydrate as 65% of total calorie intake, dietary cholesterol \<300 mg/day, dietary fiber 25 g/day.

DIETARY_SUPPLEMENT

Low fat diet

In the hypocaloric low fat diet, fat will represent less than 25% of the total energy intake. Branched and essential amino acids will be administered taking into account the total protein intake.

OTHER

Aerobic exercise

A personalized program of aerobic exercise will be prescribed to the participants of both arms, following the "FITT" principles (frequency, intensity, time and type).

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute

  collaborator OTHER

• Università degli studi di Roma Foro Italico

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• University of Roma La Sapienza

  lead OTHER

Principal Investigators

• Stefano Ginanni Corradini, MD, PhD · Department Translational and Precision Medicine, Sapienza University of Rome

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2021-09-30

Completion

2022-02-28

Countries

• Italy

Study Locations