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

Not Applicable

• Conditions: NAFLD
• Interventions: Behavioral: LGIMD; Behavioral: Endurance Activity (EA); Behavioral: EA+Resistance Training (RT); Behavioral: LGIMD+EA; Behavioral: LGIMD+EA/RT; Behavioral: Control

• Registration Number: NCT02347696
• Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Brief 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.

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-27
• Study Start: 2015-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Non-Alcoholic Fatty liver Disease (NAFLD) score	up to 12 weeks	NAFLD score will be built with Fobroscan-CAP

Secondary Outcome Measures

Name	Time	Method
Sierical lipid profile	6 and 12 weeks
Lipid composition of erythrocyte membrane	6 and 12 weeks

Trial Locations

Locations (1)

Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis; 🇮🇹 Castellana Grotte, BA, Italy