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.

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.

Study Overview

• Status: Unknown
• Conditions: NAFLD
• Intervention / Treatment: Behavioral: Control; Behavioral: LGIMD; Behavioral: Endurance Activity (EA); Behavioral: EA+Resistance Training (RT); Behavioral: LGIMD+EA; Behavioral: LGIMD+EA/RT

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto R Osella, MD, PhD; Phone Number: 00390804994655; Email: arosella@irccsdebellis.it

Study Locations

• Italy
  • BA
    • Castellana Grotte, BA, Italy, 70013
      • Recruiting
      • Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
      • Contact: Isabella Franco, BSc; Phone Number: 00390804994650; Email: isabella.franco@irccsdebellis.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Alcoholic Fatty liver Disease (NAFLD) score	NAFLD score will be built with Fobroscan-CAP	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Lipid composition of erythrocyte membrane	6 and 12 weeks
Sierical lipid profile	6 and 12 weeks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
• Investigators: Principal Investigator: Alberto R Osella, MD, PhD, IRCCS "Saverio de Bellis"

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: January 26, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Physical Activity; Diet; Trial; Lipidomics; Occidental Diseases
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NUTRIATT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When data analysis will finish