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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02364661
Other study ID # 0601-14-RMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 5, 2015
Last updated February 10, 2015
Start date March 2015

Study information

Verified date February 2015
Source Rabin Medical Center
Contact Amir Shlomai, MD/PhD
Phone 972-3-9377250
Email amirsh9@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Hepatitis B virus patients with detectable viremia

- >18 years old

- signed a consent form

Exclusion Criteria:

- 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 -

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Over night starvation (fasting)
HBV viral load will be analyzed after over-night starvation versus following a morning meal

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

References & 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. Epub 2006 Oct 16. — View Citation

Shlomai 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). No
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