The Influence of Short-term Starvation on Hepatitis B Virus Load
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus infects the liver and previous studies, done in tissue culture and in animals, have shown that viral replication is affected by metabolic changes occurring in the liver. Specifically, starvation induces HBV gene expression and replication, in parallel to the activation of the gluconeogenesis response, and feeding attenuates viral activity. In this study we are going to recruit HBV patients with detectable viremia and analyze their viral load after an over night starvation versus after a morning meal. Our hypothesis is that following an over-night starvation viral load will be higher than that in the fed state.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedFebruary 18, 2015
February 1, 2015
1 year
February 5, 2015
February 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states
Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all).
Study Arms (1)
Hepatitis B virus infected patients
EXPERIMENTALHBV patients with detectable viremia will be analyzed for their level of viremia following an over-night starvation (fasting) versus fed state
Interventions
HBV viral load will be analyzed after over-night starvation versus following a morning meal
Eligibility Criteria
You may qualify if:
- Hepatitis B virus patients with detectable viremia
- \>18 years old
- signed a consent form
You may not qualify if:
- patients with malignancy
- Patients with diabetes mellitus
- Alcohol consumption of more than 140grams a week
- Advanced liver disease
- HCV or HIV infection
- Pregnancy
- Mental retardation or unable to understand basic explanation about the study -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Shlomai A, Paran N, Shaul Y. PGC-1alpha controls hepatitis B virus through nutritional signals. Proc Natl Acad Sci U S A. 2006 Oct 24;103(43):16003-8. doi: 10.1073/pnas.0607837103. Epub 2006 Oct 16.
PMID: 17043229BACKGROUNDShlomai A, Shaul Y. The "metabolovirus" model of hepatitis B virus suggests nutritional therapy as an effective anti-viral weapon. Med Hypotheses. 2008;71(1):53-7. doi: 10.1016/j.mehy.2007.08.032. Epub 2008 Mar 10.
PMID: 18334285BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Shlomai, MD/PhD
Rabin Medical Center, Beilinson hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 5, 2015
First Posted
February 18, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Last Updated
February 18, 2015
Record last verified: 2015-02