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

Primary Purpose

Flushing

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Quercetin

Placebo

About this trial

This is an interventional supportive care trial for Flushing focused on measuring Skin, pharmacology, metabolism, lipid

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Quercetin 500 mg

Quercetin 1000 mg

Quercetin 2000 mg

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00913081

First Posted

May 29, 2009

Last Updated

February 19, 2015

Sponsor

University of Pennsylvania

Collaborators

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00913081

Brief Title

Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

Acronym

ANTI-FLUSH

Official Title

Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flushing

Keywords

Skin, pharmacology, metabolism, lipid

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Quercetin 500 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Quercetin 1000 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Quercetin 2000 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Quercetin

Other Intervention Name(s)

Isoquercetin

Intervention Description

Quercetin 500, 1000, or 2000 mg PO one time

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo PO one time

Primary Outcome Measure Information:

Title

Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin

Description

Time Frame

8 hour period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard L. Dunbar, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Phila

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

University of Pennsylvania

City

Phila

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

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