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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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BA
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Castellana Grotte, BA, Italien, 70013
- Rekrutierung
- Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
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Kontakt:
- Isabella Franco, BSc
- Telefonnummer: 00390804994650
- E-Mail: isabella.franco@irccsdebellis.it
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: 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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Sonstiges: 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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Sonstiges: 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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Sonstiges: 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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Sonstiges: 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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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Non-Alcoholic Fatty liver Disease (NAFLD) score
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Lipid composition of erythrocyte membrane
Zeitfenster: 6 and 12 weeks
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6 and 12 weeks
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Sierical lipid profile
Zeitfenster: 6 and 12 weeks
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6 and 12 weeks
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Alberto R Osella, MD, PhD, IRCCS "Saverio de Bellis"
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NUTRIATT
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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