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

Clalit Health Services

Status: Unknown

Conditions: Infection; Starvation

Treatments: Behavioral: Over night starvation (fasting)

Study type: Interventional

Funder types: Other

Identifiers

NCT02364661

0601-14-RMC

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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 -

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Hepatitis B virus infected patients

Experimental group

Description:

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

Treatment:

Behavioral: Over night starvation (fasting)