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

NCT ID: NCT02364661

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Starvation Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Hepatitis B virus infected patients

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

Group Type EXPERIMENTAL

Over night starvation (fasting)

Intervention Type BEHAVIORAL

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

Interventions

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Over night starvation (fasting)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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AMIR SHLOMAI

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Shlomai, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center, Beilinson hospital

Central Contacts

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Amir Shlomai, MD/PhD

Role: CONTACT

972-3-9377250

Shulamit Greenstein, PhD

Role: CONTACT

972-3-9377250

References

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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.

Reference Type BACKGROUND
PMID: 17043229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18334285 (View on PubMed)

Other Identifiers

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0601-14-RMC

Identifier Type: -

Identifier Source: org_study_id

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