Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease

NCT ID: NCT01798719

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-11-30

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.

Conditions

NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diet: Dietary Advice

Some general dietary advice about healthy dietary components, servings size and frequency of servings

Group Type: PLACEBO_COMPARATOR

General Advice

Intervention Type: BEHAVIORAL

Only general advice about diet

Low glycemic index Mediterranean Diet

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)

Group Type: EXPERIMENTAL

Low Glycemic Index Mediterranean Diet

Intervention Type: BEHAVIORAL

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)

Interventions

Low Glycemic Index Mediterranean Diet

A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)

Intervention Type: BEHAVIORAL

General Advice

Only general advice about diet

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role: lead

Responsible Party

Alberto R Osella

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto R Osella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Saverio de Bellis

Giovanni Misciagna, MD, PhD

Role: STUDY_DIRECTOR

IRCCS Saverio de Bellis

Locations

Laboratory of Epidemiology and Biostatistics, IRCCS Saverio de Bellis

Castellana Grotte, BA, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 19638964 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32476140 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28346567 (View on PubMed)

Other Identifiers

EPINUT3

Identifier Type: -

Identifier Source: org_study_id