Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH) (ANTI-FLUSH)

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.

Study Overview

• Status: Completed
• Conditions: Flushing
• Intervention / Treatment: Dietary supplement: Quercetin; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Phila, Pennsylvania, United States, 19104
      • CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor
    • Phila, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Contra-indications or known intolerance to the study medications.
2. History of congestive heart failure, carcinoid, rosacea, renal failure (GFR<60 ml/min/m2).
3. Active liver disease.
4. 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.
5. 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.
6. History of drug abuse within the past 3 years, or regular alcohol use of greater than 14 drinks per week.
7. Women who are pregnant, plan to conceive or lactate.
8. Peri-menopausal women or women currently experiencing flushing.
9. Currently taking vasoactive medications, anti-hypertensives, anti-histamines, Selective Serotonin Re-uptake Inhibitors (SSRIs), NSAIDS, oral steroids, leukotriene inhibitors, supplemental quercetin and > 50mg niacin.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quercetin 500 mg; Quercetin 500 mg once, administered one hour before 500 mg immediate-release niacin	Dietary supplement: Quercetin; Quercetin 500, 1000, or 2000 mg PO one time; Other Names: Isoquercetin
Experimental: Quercetin 1000 mg; Quercetin 1000 mg once, administered one hour before 500 mg immediate-release niacin	Dietary supplement: Quercetin; Quercetin 500, 1000, or 2000 mg PO one time; Other Names: Isoquercetin
Experimental: Quercetin 2000 mg; Quercetin 2000 mg once, administered one hour before 500 mg immediate-release niacin	Dietary supplement: Quercetin; Quercetin 500, 1000, or 2000 mg PO one time; Other Names: Isoquercetin
Placebo Comparator: Placebo; Placebo once, administered one hour before 500 mg immediate-release niacin	Dietary supplement: Placebo; Placebo PO one time

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Abbott
• Investigators: Principal Investigator: Richard L. Dunbar, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 29, 2009
• First Submitted That Met QC Criteria: June 2, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Skin; metabolism; lipid; pharmacology
• Additional Relevant MeSH Terms: Skin Manifestations; Flushing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: IRB #808911