NCT02347696

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• NAFLD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-01-27
• Last updated: 2016-07-26

Locations

1 site across 1 country: Italy