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A Nutritional Approach to Minimal Hepatic Encephalopathy

Not Applicable
Conditions
Minimal Hepatic Encephalopathy
Interventions
Other: Nutritional Intervention
Registration Number
NCT01083446
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Brief Summary

This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
Inclusion Criteria
  • All consented adults (age > 18), with the diagnosis of CHILD A cirrhosis with MELD score of < 10.
  • Diagnosis of liver cirrhosis as documented by liver biopsy (stage IV) and / or fibroscan (score > 12 kpa) and / or fibrotest (score > 0.74) and /or imaging.
Exclusion Criteria
  • History of > grade II hepatic encephalopathy (HE).
  • Diagnosis of dementia, Parkinson disease, Schizophrenia (Patients with major depression will be noted but not excluded).
  • Use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling Use of antibiotics for any length of period during and/or 2 weeks prior to enrolling.
  • Current use of lactulose or neomycin.
  • Use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BNutritional InterventionNutritional Intervention, fast
ANutritional InterventionNutritional intervention, standard Israeli breakfast
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

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