Clinical Trial: Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)

Brief Summary: Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess whether a presently available dietary supplement known as quercetin, which is a flavonoid, can reduce the flushing that occurs with niacin. We will also assess whether using quercetin to prevent flushing from niacin, can improve how niacin lowers cholesterol.

Detailed Summary: This study involves people between 21 and 75 years. It will be conducted over a period of 8 weeks, with 4 visits, each separated by 2 weeks. The duration of each visit is 9-10 hours. We will test a different dose of quercetin in each visit.
Sponsor: University of Pennsylvania

Current Primary Outcome: Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin [ Time Frame: 8 hour period ]

Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.


Original Primary Outcome: Aim 1 is to assess whether the flavonoid quercetin inhibits niacin-induced flushing in a dose-responsive fashion and compared to placebo. [ Time Frame: 8 hour period ]

Current Secondary Outcome:

Original Secondary Outcome: Aim 2 is to assess whether the flushing inhibition with quercetin enhances the anti-lipolytic benefit of niacin in a dose-responsive fashion and compared to placebo. Subjects will be monitored over an 8 hour period. [ Time Frame: 8 hour period ]

Information By: University of Pennsylvania

Dates:
Date Received: May 29, 2009
Date Started: February 2009
Date Completion:
Last Updated: February 19, 2015
Last Verified: November 2011