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Effect of Mediterranean Diet on Non-alcoholic Fatty Liver Disease

Low Glycemic Index Mediterranean Diet Effect on Moderate or Severe Non-alcoholic Fatty Liver Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01798719
Acronym
Nutriepa
Enrollment
50
Registered
2013-02-26
Start date
2011-02-28
Completion date
2011-11-30
Last updated
2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD

Keywords

NAFLD, Clinical Trial, Mediterranean Diet, Low Glycemic Index

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.

Interventions

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

BEHAVIORALGeneral Advice

Only general advice about diet

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Non-alcoholic Fatty Liver Disease Ultrasonography ScoreSix monthsA semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026