Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease (Nutriepa)
Primary Purpose
NAFLD
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Low Glycemic Index Mediterranean Diet
General Advice
Sponsored by
About this trial
This is an interventional treatment trial for NAFLD focused on measuring NAFLD, Clinical Trial, Mediterranean Diet, Low Glycemic Index
Eligibility Criteria
Inclusion Criteria:
- Subject enrolled in the cohort Nutriep assembled in 2005-2007
- Moderate or severe NAFLD
Exclusion Criteria:
- Middle NAFLD
- Not enrolled in the Nutriep cohort
- Pregnancy
Sites / Locations
- Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Diet: Dietary Advice
Low glycemic index Mediterranean Diet
Arm Description
Some general dietary advice about healthy dietary components, servings size and frequency of servings
Low glycemic index Mediterranean Diet prescription with indication about type of foods than can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)
Outcomes
Primary Outcome Measures
Non-alcoholic Fatty Liver Disease Ultrasonography Score
A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used
Secondary Outcome Measures
Full Information
NCT ID
NCT01798719
First Posted
February 22, 2013
Last Updated
February 26, 2013
Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
1. Study Identification
Unique Protocol Identification Number
NCT01798719
Brief Title
Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease
Acronym
Nutriepa
Official Title
Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
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
Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated with the metabolic syndrome. As the disease stems from excess calorie intake and lack of physical activity, the correction of unhealthy lifestyles is the background of any prevention and treatment strategy
Detailed Description
The majority of NAFLD patients are characterized by high body mass index, insulin resistance and they show a remarkably higher energy intake in comparison to individuals without hepatic steatosis. Several authors have proposed dietary weight loss strategies to ameliorate or reverse fatty liver because of the potential role of weight loss on the supposed risk factors of liver injury, mainly insulin resistance, free fatty acid levels, and pro-inflammatory and profibrotic adipokines. There are no definite data regarding how much and how rapidly weight loss should be to have the more favorable effects, but in obese children, the larger the weight loss, the larger the decrease of liver enzyme levels and the lower the prevalence of NAFLD. The American Gastroenterological Association recommends a weight loss target of 10% of baseline. A loss of at least 10% of body weight in obese patients is associated with a normalization of previously abnormal liver function tests as well as decreased hepatomegaly, but even a moderate weight loss (approximately 6% of baseline weight) can improve insulin resistance and intrahepatic liver content.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD
Keywords
NAFLD, Clinical Trial, Mediterranean Diet, Low Glycemic Index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet: Dietary Advice
Arm Type
Placebo Comparator
Arm Description
Some general dietary advice about healthy dietary components, servings size and frequency of servings
Arm Title
Low glycemic index Mediterranean Diet
Arm Type
Experimental
Arm Description
Low glycemic index Mediterranean Diet prescription with indication about type of foods than can be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)
Intervention Type
Behavioral
Intervention Name(s)
Low Glycemic Index Mediterranean Diet
Intervention Description
A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)
Intervention Type
Behavioral
Intervention Name(s)
General Advice
Intervention Description
Only general advice about diet
Primary Outcome Measure Information:
Title
Non-alcoholic Fatty Liver Disease Ultrasonography Score
Description
A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject enrolled in the cohort Nutriep assembled in 2005-2007
Moderate or severe NAFLD
Exclusion Criteria:
Middle NAFLD
Not enrolled in the Nutriep cohort
Pregnancy
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
First Name & Middle Initial & Last Name & Degree
Giovanni Misciagna, MD, PhD
Organizational Affiliation
IRCCS Saverio de Bellis
Official's Role
Study Director
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
19638964
Citation
Cozzolongo R, Osella AR, Elba S, Petruzzi J, Buongiorno G, Giannuzzi V, Leone G, Bonfiglio C, Lanzilotta E, Manghisi OG, Leandro G; NUTRIHEP Collaborating Group; Donnaloia R, Fanelli V, Mirizzi F, Parziale L, Crupi G, Detomaso P, Labbate A, Zizzari S, Depalma M, Polignano A, Lopinto D, Daprile G. Epidemiology of HCV infection in the general population: a survey in a southern Italian town. Am J Gastroenterol. 2009 Nov;104(11):2740-6. doi: 10.1038/ajg.2009.428. Epub 2009 Jul 28.
Results Reference
background
PubMed Identifier
32476140
Citation
Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.
Results Reference
derived
PubMed Identifier
28346567
Citation
Misciagna G, Del Pilar Diaz M, Caramia DV, Bonfiglio C, Franco I, Noviello MR, Chiloiro M, Abbrescia DI, Mirizzi A, Tanzi M, Caruso MG, Correale M, Reddavide R, Inguaggiato R, Cisternino AM, Osella AR. Effect of a Low Glycemic Index Mediterranean Diet on Non-Alcoholic Fatty Liver Disease. A Randomized Controlled Clinici Trial. J Nutr Health Aging. 2017;21(4):404-412. doi: 10.1007/s12603-016-0809-8.
Results Reference
derived
Learn more about this trial
Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease
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