Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.
NCT ID: NCT02347696
Last Updated: 2016-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2015-03-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
The subjects will follow a diet based on INRAN guidelines without doing any physical activity.
Control
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
LGIMD
The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity.
LGIMD
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
Endurance Activity (EA)
The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet.
Endurance Activity (EA)
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.
EA+Resistance Training (RT)
The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet.
EA+Resistance Training (RT)
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
LGIMD+EA
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA).
LGIMD+EA
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
LGIMD+EA/RT
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT).
LGIMD+EA/RT
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
Interventions
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Control
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
LGIMD
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
Endurance Activity (EA)
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.
EA+Resistance Training (RT)
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
LGIMD+EA
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
LGIMD+EA/RT
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
Eligibility Criteria
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Inclusion Criteria
* Moderate or severe NAFLD
* 30 \< age \<60
Exclusion Criteria
* 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.
30 Years
60 Years
ALL
No
Sponsors
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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
OTHER
Responsible Party
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Alberto R Osella
MD, PhD
Principal Investigators
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Alberto R Osella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS "Saverio De Bellis"
Locations
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Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
Castellana Grotte, BA, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NUTRIATT
Identifier Type: -
Identifier Source: org_study_id
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