Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

NCT00913081 | Completed Phase 4 Results

• 1 other identifier: IRB #808911
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Flushing

Keywords

Skin; pharmacology; metabolism; lipid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Quercetin 500 mg

EXPERIMENTAL

Quercetin 500 mg once, administered one hour before 500 mg immediate-release niacin

Dietary Supplement: Quercetin

Quercetin 1000 mg

EXPERIMENTAL

Quercetin 1000 mg once, administered one hour before 500 mg immediate-release niacin

Dietary Supplement: Quercetin

Quercetin 2000 mg

EXPERIMENTAL

Quercetin 2000 mg once, administered one hour before 500 mg immediate-release niacin

Dietary Supplement: Quercetin

Placebo

PLACEBO COMPARATOR

Placebo once, administered one hour before 500 mg immediate-release niacin

Dietary Supplement: Placebo

Interventions

Quercetin DIETARY_SUPPLEMENT

Quercetin 500, 1000, or 2000 mg PO one time

Also known as: Isoquercetin

Quercetin 1000 mg; Quercetin 2000 mg; Quercetin 500 mg

Placebo DIETARY_SUPPLEMENT

Placebo PO one time

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Abbott: collaborator

Study Sites (2)

CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Flushing

Interventions

Quercetin; isoquercitrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Richard L. Dunbar, MD, PI
• Organization: University of Pennsylvania

richard.dunbar@uphs.upenn.edu

609 413-1067

Study Officials

• Richard L. Dunbar, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 3, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 5, 2015
• Results First Posted: March 5, 2015

Record last verified: 2011-11

Locations

US (2)