Body Composition, Adiposity Phenotype, Metabolic Flexibility, and Gut Microbiota in PNPLA3 and TM6SF2 Gene Variant Carriers and Non-carriers With Nonalcoholic Fatty Liver Disease. Effects of a Nutritional Intervention Combined to Exercise

Status: Completed
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• body mass index (BMI) \> 30 Kg/m2 and \< 40 Kg/m2;

• Caucasian Italian subjects

• hepatic steatosis according with ultrasonographic Hamaguchi's criteria and/or hypertransaminasemia (ALT \>30 IU/L in men and \>20 IU/L in women)

Locations
Other Locations
Italy
Department of Translational and Precision Medicine, Sapienza University of Rome, Umberto I Hospital
Rome
Time Frame
Start Date: 2016-10
Completion Date: 2022-02
Participants
Target number of participants: 120
Treatments
Experimental: Mediterranean diet
Hypocaloric Mediterranean diet for a 4-month period;~Aerobic exercise training for a 4-month period;
Experimental: Low fat diet
Hypocaloric low fat diet supplemented by branched and essential amino acids considering the total protein intake for a 4- month period;~Aerobic exercise training for a 4- month period;
Related Therapeutic Areas
Sponsors
Collaborators: Università degli studi di Roma Foro Italico, Göteborg University, Bambino Gesù Hospital and Research Institute
Leads: University of Roma La Sapienza

This content was sourced from clinicaltrials.gov