Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

NCT ID: NCT00913081

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-12-31

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.

Conditions

Flushing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Quercetin 500 mg

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

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DIETARY_SUPPLEMENT

Quercetin 500, 1000, or 2000 mg PO one time

Quercetin 1000 mg

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

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DIETARY_SUPPLEMENT

Quercetin 500, 1000, or 2000 mg PO one time

Quercetin 2000 mg

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

Group Type: EXPERIMENTAL

Quercetin

Intervention Type: DIETARY_SUPPLEMENT

Quercetin 500, 1000, or 2000 mg PO one time

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo PO one time

Interventions

Quercetin

Quercetin 500, 1000, or 2000 mg PO one time

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo PO one time

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Isoquercetin

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard L. Dunbar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB #808911

Identifier Type: -

Identifier Source: org_study_id