Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.
Effect of Two Programs of Physical Activity of Different Intensity, Mediterranean Diet and the Combination of Both on NAFLD and Erytrocyte Membrane Lipid Profile.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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BA
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Castellana Grotte, BA, Italia, 70013
- Reclutamiento
- Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
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Contacto:
- Isabella Franco, BSc
- Número de teléfono: 00390804994650
- Correo electrónico: isabella.franco@irccsdebellis.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Control
The subjects will follow a diet based on INRAN guidelines without doing any physical activity.
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Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
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Otro: LGIMD
The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity.
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Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
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Otro: Endurance Activity (EA)
The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet.
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Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity:
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Otro: EA+Resistance Training (RT)
The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet.
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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):
Resistance activity: Muscolation: Training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutes and legs);
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Otro: LGIMD+EA
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA).
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Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
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Otro: 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).
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Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Non-Alcoholic Fatty liver Disease (NAFLD) score
Periodo de tiempo: up to 12 weeks
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NAFLD score will be built with Fobroscan-CAP
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up to 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Lipid composition of erythrocyte membrane
Periodo de tiempo: 6 and 12 weeks
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6 and 12 weeks
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Sierical lipid profile
Periodo de tiempo: 6 and 12 weeks
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6 and 12 weeks
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Alberto R Osella, MD, PhD, IRCCS "Saverio de Bellis"
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NUTRIATT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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