Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

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.

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Key information

Conditions

Flushing Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor, Philadelphia, Pennsylvania, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women from the age of 21 to 75, inclusive - 16 subjects, 8 men, 8 women.
Ability to understand and agree to informed consent.
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

Exclusion criteria

Contra-indications or known intolerance to the study medications.
History of congestive heart failure, carcinoid, rosacea, renal failure (GFR<60 ml/min/m2).
Active liver disease.
Active diabetes (defined as any history of type 1 diabetes, or history of type 2 diabetes plus one or more of the following: fasting glucose>= 126mg/dL at screening or use of anti-diabetic medications within 12 months, or glucose>200mg/dL 2 hours after a 75 g oral glucose challenge within 12 months.
History of major surgery within the past 6 weeks, or anticipated major surgery during the course of the study, or any history of organ transplant.
History of drug abuse within the past 3 years, or regular alcohol use of greater than 14 drinks per week.
Women who are pregnant, plan to conceive or lactate.
Peri-menopausal women or women currently experiencing flushing.
Currently taking vasoactive medications, anti-hypertensives, anti-histamines, Selective Serotonin Re-uptake Inhibitors (SSRIs), NSAIDS, oral steroids, leukotriene inhibitors, supplemental quercetin and > 50mg niacin.

Treatment and study plan

Quercetin

Dietary Supplement

Quercetin 500, 1000, or 2000 mg PO one time

Other names: Isoquercetin

Placebo

Dietary Supplement

Placebo PO one time

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

Abbott

Registry information

Official study title

Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)

Acronym: ANTI-FLUSH

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jun 3, 2009
Registry last updated: Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed