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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | The subjects will follow a diet based on INRAN guidelines without doing any physical activity. |
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| LGIMD | Other | The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity. |
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| Endurance Activity (EA) | Other | The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet. |
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| EA+Resistance Training (RT) | Other | The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet. |
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| LGIMD+EA | Other | The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA). |
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| LGIMD+EA/RT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Behavioral | Subjects will follow a diet based on INRAN guidelines without doing any physical activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Non-Alcoholic Fatty liver Disease (NAFLD) score | NAFLD score will be built with Fobroscan-CAP | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid composition of erythrocyte membrane | 6 and 12 weeks | |
| Sierical lipid profile | 6 and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto R Osella, MD, PhD | Contact | 00390804994655 | arosella@irccsdebellis.it |
| Name | Affiliation | Role |
|---|---|---|
| Alberto R Osella, MD, PhD | IRCCS "Saverio De Bellis" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis | Recruiting | Castellana Grotte | BA | 70013 | Italy |
When data analysis will finish
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
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The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT). |
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| LGIMD | Behavioral | Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity. |
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| Endurance Activity (EA) | Behavioral | Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity:
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| EA+Resistance Training (RT) | Behavioral | Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity (for Endurance activity):
Resistance activity: Muscolation: Training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutes and legs);
|
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| LGIMD+EA | Behavioral | Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity. |
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| LGIMD+EA/RT | Behavioral | Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training. |
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