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

Plain-language summary

This study examined, on a genetic basis, the effects of a Mediterranean diet, a low-fat diet and aerobic exercise on metabolic flexibility and gut microbiota in people with non-alcoholic fatty liver disease (NAFLD). It included Caucasian Italian individuals with a body mass index between 30 and 40 who had hepatic steatosis. It was a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Roma La Sapienza

Intervention

Mediterranean diet, Low fat diet, Aerobic exercise

Start date

10/1/2016

Estimated completion

2/1/2022

Countries

Italy

Related genes

Locations

• Rome, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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)

Exclusion Criteria:

* any malignant disease during the last 5 years;
* any inflammatory or autoimmune disease;
* corticosteroids for systemic use;
* renal failure (GFR\<90 ml/min);
* heart failure (NYHA classes II-IV);
* history of viral or autoimmune liver disease;
* any cause cirrhosis;
* excessive alcohol intake (\>140g/week for men and 70g/week for women);
* participation in a reducing-weight program in the last 3 months;
* level of physical activity higher than 3 METs;
* therapy with antibiotics during the last 3 months;
* bile salts, cholestyramine during the last 6 months before enrollment;
* previous cholecystectomy;
* gallbladder disease