A Nutritional Approach to Minimal Hepatic Encephalopathy
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2008
Typical duration for not_applicable
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
June 17, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedMarch 9, 2010
June 1, 2008
2 years
June 17, 2008
March 8, 2010
Conditions
Keywords
Study Arms (2)
A
ACTIVE COMPARATORNutritional intervention, standard Israeli breakfast
B
ACTIVE COMPARATORNutritional Intervention, fast
Interventions
Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, Israel
Related Publications (1)
Vaisman N, Katzman H, Carmiel-Haggai M, Lusthaus M, Niv E. Breakfast improves cognitive function in cirrhotic patients with cognitive impairment. Am J Clin Nutr. 2010 Jul;92(1):137-40. doi: 10.3945/ajcn.2010.29211. Epub 2010 May 5.
PMID: 20444959DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nachum Vaisman, Prof'
Tel-Aviv Sourasky Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
June 17, 2008
First Posted
March 9, 2010
Study Start
July 1, 2008
Primary Completion
July 1, 2010
Study Completion
August 1, 2010
Last Updated
March 9, 2010
Record last verified: 2008-06