This study aims to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.
The surveys conducted on the populations of Castellana Grotte and Putignano (Bari, Italy) evidenced that Non-Alcoholic Fatty liver Disease (NAFLD) reaches a prevalence of 30%, especially among aged and male individuals. Being a crucial outcome of several metabolic alterations, it becomes imperative for Public Health to adopt strategies aimed to control the factors responsible for NAFLD onset. The objective of this study is to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane. Study participants responding to the inclusion criteria of this trial will be chosen both in the hospital setting and in the general practitioners' clinics. At the enrollement, anthropometric and biochemical variables will be measured, as well as bioimpedenziometric and calorimetric parameters; participants will also undergo Fibroscan-CAP to measure the outcome and will be asked about their medical history and life-style. Subjects will be randomized to the different arms of the trial and be followed-up at the end of the sixth and the twelfth week of enrollement. All data will be statistically analysed by applying the Chi-Square test and t-test for discrete and continuous variables, respectively. As it deals with the analysis of data repeatedly measured on the same subject, the Generalized Estimating Equation (GEE) will be applied to evaluate the effect of the intervention on the outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity: * weeks 1-4: 14.2 kcal\*kg-1\*week-1; * weeks 5-8: 18.9 kcal\*kg-1\*week-1; * weeks 9-12: 23.6 kcal\*kg-1\*week-1.
Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
Castellana Grotte, BA, Italy
RECRUITINGNon-Alcoholic Fatty liver Disease (NAFLD) score
NAFLD score will be built with Fobroscan-CAP
Time frame: up to 12 weeks
Lipid composition of erythrocyte membrane
Time frame: 6 and 12 weeks
Sierical lipid profile
Time frame: 6 and 12 weeks
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Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity (for Endurance activity): * weeks 1-4: 14.2 kcal\*kg-1\*week-1; * weeks 5-8: 18.9 kcal\*kg-1\*week-1; * weeks 9-12: 23.6 kcal\*kg-1\*week-1. Resistance activity: Muscolation: Training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutes and legs); * Progression: increase of 1-2.5 kg\*week-1 * Training of all muscle groups in the same session
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.