Clinical Trials Directory

Trials / Completed

CompletedNCT00913081

Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
17 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
21 Years – 75 Years
Healthy volunteers
Accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTQuercetinQuercetin 500, 1000, or 2000 mg PO one time
DIETARY_SUPPLEMENTPlaceboPlacebo PO one time

Timeline

Start date
2009-02-01
Primary completion
2009-08-01
Completion
2009-12-01
First posted
2009-06-03
Last updated
2015-03-05
Results posted
2015-03-05

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00913081. Inclusion in this directory is not an endorsement.