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

25. juli 2016 opdateret af: Alberto R Osella, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • BA
      • Castellana Grotte, BA, Italien, 70013
        • Rekruttering
        • Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Control
The subjects will follow a diet based on INRAN guidelines without doing any physical activity.
Adfærdsmæssigt: Control
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
Andet: LGIMD
The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity.
Adfærdsmæssigt: LGIMD
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
Andet: Endurance Activity (EA)
The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet.
Adfærdsmæssigt: 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.
Andet: EA+Resistance Training (RT)
The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet.
Adfærdsmæssigt: 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
Andet: LGIMD+EA
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA).
Adfærdsmæssigt: LGIMD+EA
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
Andet: 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).
Adfærdsmæssigt: LGIMD+EA/RT
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-Alcoholic Fatty liver Disease (NAFLD) score
Tidsramme: up to 12 weeks
NAFLD score will be built with Fobroscan-CAP
up to 12 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Lipid composition of erythrocyte membrane
Tidsramme: 6 and 12 weeks
6 and 12 weeks
Sierical lipid profile
Tidsramme: 6 and 12 weeks
6 and 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Efterforskere

  • Ledende efterforsker: Alberto R Osella, MD, PhD, IRCCS "Saverio de Bellis"

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2015

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

21. januar 2015

Først indsendt, der opfyldte QC-kriterier

26. januar 2015

Først opslået (Skøn)

27. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NUTRIATT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

When data analysis will finish

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med NAFLD

Kliniske forsøg med Control

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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