A Pilot Study of the Grapefruit Flavonoid Naringenin for HCV Infection
|Hepatitis C Virus HCV Infection Chronic HCV Hepatitis C||Dietary Supplement: Naringenin||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of the Grapefruit Flavonoid Naringenin for the Treatment of HCV Infection|
- Naringenin pharmacokinetic curves [ Time Frame: 12 hours ]Level of naringenin will be measured by HPLC at time 0, 30, 40, 90, 120, 150, and 180 min and at 4, 5, 6, 7, 8, and 12 hours.
- Safety [ Time Frame: 12 hours ]as indicated by all high-grade signs and symptoms and laboratory values.
- Changes in HCV RNA levels [ Time Frame: 12 hours ]
- Homeostatic model assessment-insulin resistance (HOMA-IR) [ Time Frame: 24 hours ]
- Lipid levels: Cholesterol and triglyceride levels [ Time Frame: 24 hours ]
- Liver enzyme levels [ Time Frame: 24 hours ]ALT and AST at entry and end of steps 1 and 2.
|Study Start Date:||June 2009|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Naringenin
Single dose of naringenin, compared to placebo in the same individual.
Dietary Supplement: Naringenin
1 gram of naringenin mixed with 16 grams of hydroxypropyl-β-cyclodextrin in 250 mL of water
Other Name: Grapefruit
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.
Treatment with naringenin will block vLDL and HCV secretion in persons infected with HCV.
To study the safety and pharmacokinetics of a single-dose of naringenin
- To study the changes in circulating HCV titers during the transition from a fasted to fed state.
- To study the changes in circulating HCV titers after administration of the grapefruit flavonoid naringenin.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091077
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Arthur Y Kim, M.D.||Massachusetts General Hospital|