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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02347696
• Other study ID #: NUTRIATT
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2015
• Last updated: July 25, 2016
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Contact: Alberto R Osella, MD, PhD
• Phone: 00390804994655
• Email: arosella[@]irccsdebellis.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Control
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
• LGIMD
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
• 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.
• 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
• LGIMD+EA
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
• LGIMD+EA/RT
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.

Locations

Country	Name	City	State
Italy	Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis	Castellana Grotte	BA

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Alcoholic Fatty liver Disease (NAFLD) score	NAFLD score will be built with Fobroscan-CAP	up to 12 weeks	No
Secondary	Lipid composition of erythrocyte membrane		6 and 12 weeks	No
Secondary	Sierical lipid profile		6 and 12 weeks	No