Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

Flushing Clinical Trial

— ANTI-FLUSH  

Official title:

Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913081
• Other study ID #: IRB #808911
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2009
• Last updated: February 19, 2015
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: November 2011
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Flushing

Intervention

Dietary Supplement:
• Quercetin
Quercetin 500, 1000, or 2000 mg PO one time
• Placebo
Placebo PO one time

Locations

Country	Name	City	State
United States	CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor	Phila	Pennsylvania
United States	University of Pennsylvania	Phila	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No