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

Primary Purpose

NAFLD

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Control
LGIMD
Endurance Activity (EA)
EA+Resistance Training (RT)
LGIMD+EA
LGIMD+EA/RT
Sponsored by
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD focused on measuring Diet, Physical Activity, Trial, Lipidomics, Occidental Diseases

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de BellisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

Control

LGIMD

Endurance Activity (EA)

EA+Resistance Training (RT)

LGIMD+EA

LGIMD+EA/RT

Arm Description

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

The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity.

The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet.

The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet.

The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA).

The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT).

Outcomes

Primary Outcome Measures

Non-Alcoholic Fatty liver Disease (NAFLD) score
NAFLD score will be built with Fobroscan-CAP

Secondary Outcome Measures

Lipid composition of erythrocyte membrane
Sierical lipid profile

Full Information

First Posted
January 21, 2015
Last Updated
July 25, 2016
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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1. Study Identification

Unique Protocol Identification Number
NCT02347696
Brief Title
Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD
Keywords
Diet, Physical Activity, Trial, Lipidomics, Occidental Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
The subjects will follow a diet based on INRAN guidelines without doing any physical activity.
Arm Title
LGIMD
Arm Type
Other
Arm Description
The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity.
Arm Title
Endurance Activity (EA)
Arm Type
Other
Arm Description
The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet.
Arm Title
EA+Resistance Training (RT)
Arm Type
Other
Arm Description
The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet.
Arm Title
LGIMD+EA
Arm Type
Other
Arm Description
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA).
Arm Title
LGIMD+EA/RT
Arm Type
Other
Arm Description
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT).
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
Intervention Type
Behavioral
Intervention Name(s)
LGIMD
Intervention Description
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Endurance Activity (EA)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EA+Resistance Training (RT)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
LGIMD+EA
Intervention Description
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
Intervention Type
Behavioral
Intervention Name(s)
LGIMD+EA/RT
Intervention Description
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
Primary Outcome Measure Information:
Title
Non-Alcoholic Fatty liver Disease (NAFLD) score
Description
NAFLD score will be built with Fobroscan-CAP
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Lipid composition of erythrocyte membrane
Time Frame
6 and 12 weeks
Title
Sierical lipid profile
Time Frame
6 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto R Osella, MD, PhD
Phone
00390804994655
Email
arosella@irccsdebellis.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto R Osella, MD, PhD
Organizational Affiliation
IRCCS "Saverio De Bellis"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
City
Castellana Grotte
State/Province
BA
ZIP/Postal Code
70013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabella Franco, BSc
Phone
00390804994650
Email
isabella.franco@irccsdebellis.it

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
When data analysis will finish

Learn more about this trial

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

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