NCT01091077

A Pilot Study of the Grapefruit Flavonoid Naringenin for HCV Infection

A Pilot Study of the Grapefruit Flavonoid Naringenin for the Treatment of HCV Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Hepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An component of grapefruit could block this fat and thus lower the amount of virus in the blood stream. We propose that treatment with this ingredient, called naringenin, could be used to block this fat and HCV in persons infected with hepatitis C.

Detailed description

The hepatitis C virus is actively secreted by the liver of infected patients while bound to very low density lipoprotein (vLDL). The grapefruit flavonoid naringenin could be used to block vLDL secretion and lower the circulating viral titer. Hypothesis: Treatment with naringenin will block vLDL and HCV secretion in persons infected with HCV. Primary Objective To study the safety and pharmacokinetics of a single-dose of naringenin Secondary Objectives 1. To study the changes in circulating HCV titers during the transition from a fasted to fed state. 2. To study the changes in circulating HCV titers after administration of the grapefruit flavonoid naringenin. 3. To study effects of naringenin on vLDL secretion. This is a single-arm, cross over study where placebo is administered during a transition from a fasted to a fed state, then the protocol is repeated with a single dose of naringenin plus cyclodextrin, using the previous measurements as his/her own control

Conditions

• Hepatitis C Virus
• HCV Infection
• Chronic HCV
• Hepatitis C

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Naringenin	1 gram of naringenin mixed with 16 grams of hydroxypropyl-β-cyclodextrin in 250 mL of water

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-03-23
• Last updated: 2015-09-23

Locations

1 site across 1 country: United States