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

Primary Purpose

Starvation, Infection

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Over night starvation (fasting)

About this trial

This is an interventional basic science trial for Starvation focused on measuring Hepatitis B virus, Metabolovirus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepatitis B virus infected patients

Arm Description

HBV patients with detectable viremia will be analyzed for their level of viremia following an over-night starvation (fasting) versus fed state

Outcomes

Primary Outcome Measures

A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states

Secondary Outcome Measures

Full Information

NCT ID

NCT02364661

First Posted

February 5, 2015

Last Updated

February 10, 2015

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02364661

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Starvation, Infection

Keywords

Hepatitis B virus, Metabolovirus

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hepatitis B virus infected patients

Arm Type

Experimental

Arm Description

HBV patients with detectable viremia will be analyzed for their level of viremia following an over-night starvation (fasting) versus fed state

Intervention Type

Behavioral

Intervention Name(s)

Over night starvation (fasting)

Intervention Description

HBV viral load will be analyzed after over-night starvation versus following a morning meal

Primary Outcome Measure Information:

Title

A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states

Time Frame

Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amir Shlomai, MD/PhD

Phone

972-3-9377250

amirsh9@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Shulamit Greenstein, PhD

Phone

972-3-9377250

ShulamithG@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amir Shlomai, MD/PhD

Organizational Affiliation

Rabin Medical Center, Beilinson hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

17043229

Citation

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.

Results Reference

background

PubMed Identifier

18334285

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.

Results Reference

background

Learn more about this trial

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

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