Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Flushing

Intervention / Treatment
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* Dietary Supplement: Quercetin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quercetin 500 mg<br>Quercetin 500 mg once, administered one hour before 500 mg immediate-release niacin | Dietary Supplement: Quercetin<br>* Quercetin 500, 1000, or 2000 mg PO one time<br>* Other names: Isoquercetin;|
| Experimental: Quercetin 1000 mg<br>Quercetin 1000 mg once, administered one hour before 500 mg immediate-release niacin | Dietary Supplement: Quercetin<br>* Quercetin 500, 1000, or 2000 mg PO one time<br>* Other names: Isoquercetin;|
| Experimental: Quercetin 2000 mg<br>Quercetin 2000 mg once, administered one hour before 500 mg immediate-release niacin | Dietary Supplement: Quercetin<br>* Quercetin 500, 1000, or 2000 mg PO one time<br>* Other names: Isoquercetin;|
| Placebo Comparator: Placebo<br>Placebo once, administered one hour before 500 mg immediate-release niacin | Dietary Supplement: Placebo<br>* Placebo PO one time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin | 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. | 8 hour period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin, metabolism, pharmacology, lipid