The Influence of Short-term Starvation on Hepatitis B Virus Load

Infection Clinical Trial

Official title:

The Influence of Short-term Starvation on Disease Severity and Viral Replication Among Hepatitis B Virus Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02364661
• Other study ID #: 0601-14-RMC
• 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. 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

• Hepatitis B
• Infection
• Starvation

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