Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Two Programs of Physical Activity of Different Intensity, Mediterranean Diet and the Combination of Both on NAFLD and Erytrocyte Membrane Lipid Profile.

Conditions
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NAFLD

Intervention / Treatment
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* Behavioral: Control
* Behavioral: LGIMD
* Behavioral: Endurance Activity (EA)
* Behavioral: EA+Resistance Training (RT)
* Behavioral: LGIMD+EA
* Behavioral: LGIMD+EA/RT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI ≥ 25.0 Moderate or severe NAFLD 30 < age <60 Exclusion Criteria: Overt cardiovascular disease and revascularization procedures; Stroke; Clinical peripheral artery disease; Type-2 Diabetes Mellitus (current treatment with insulin or oral hypoglycemic drugs, fasting glucose >126 mg/dl, or casual glucose >200 mg/dl); Severe medical condition that may impair the person to participate in a nutritional intervention study; Impossibility to follow Mediterranean Diet for religious or other reasons.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>The subjects will follow a diet based on INRAN guidelines without doing any physical activity. | Behavioral: Control<br>* Subjects will follow a diet based on INRAN guidelines without doing any physical activity.<br>|
| Other: LGIMD<br>The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity. | Behavioral: LGIMD<br>* Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.<br>|
| Other: Endurance Activity (EA)<br>The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet. | Behavioral: Endurance Activity (EA)<br>* 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.<br>|
| Other: EA+Resistance Training (RT)<br>The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet. | Behavioral: EA+Resistance Training (RT)<br>* 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<br>|
| Other: LGIMD+EA<br>The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA). | Behavioral: LGIMD+EA<br>* Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.<br>|
| Other: LGIMD+EA/RT<br>The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT). | Behavioral: LGIMD+EA/RT<br>* Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Alcoholic Fatty liver Disease (NAFLD) score | NAFLD score will be built with Fobroscan-CAP | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid composition of erythrocyte membrane |  | 6 and 12 weeks | 
| Sierical lipid profile |  | 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Physical Activity, Trial, Lipidomics, Occidental Diseases