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.
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 26, 2016
July 1, 2016
1.8 years
January 21, 2015
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-Alcoholic Fatty liver Disease (NAFLD) score
NAFLD score will be built with Fobroscan-CAP
up to 12 weeks
Secondary Outcomes (2)
Lipid composition of erythrocyte membrane
6 and 12 weeks
Sierical lipid profile
6 and 12 weeks
Study Arms (6)
Control
OTHERThe subjects will follow a diet based on INRAN guidelines without doing any physical activity.
LGIMD
OTHERThe subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity.
Endurance Activity (EA)
OTHERThe subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet.
EA+Resistance Training (RT)
OTHERThe subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet.
LGIMD+EA
OTHERThe subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA).
LGIMD+EA/RT
OTHERThe subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT).
Interventions
Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
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.
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
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
Eligibility Criteria
You may qualify if:
- BMI ≥ 25.0
- Moderate or severe NAFLD
- \< age \<60
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
Castellana Grotte, BA, 70013, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto R Osella, MD, PhD
IRCCS "Saverio De Bellis"
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
January 21, 2015
First Posted
January 27, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share
When data analysis will finish