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

NCT02347696 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-07-26

No results posted yet for this study

Summary

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.

Conditions

  • NAFLD

Interventions

BEHAVIORAL

Control

Subjects will follow a diet based on INRAN guidelines without doing any physical activity.

BEHAVIORAL

LGIMD

Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.

BEHAVIORAL

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.

BEHAVIORAL

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

BEHAVIORAL

LGIMD+EA

Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.

BEHAVIORAL

LGIMD+EA/RT

Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.

Sponsors & Collaborators

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Principal Investigators

  • Alberto R Osella, MD, PhD · IRCCS "Saverio De Bellis"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02347696 on ClinicalTrials.gov