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

• ClinicalTrials.gov Identifier: NCT00913081
• Recruitment Status: Completed
• First Posted: June 3, 2009
• Results First Posted: March 5, 2015
• Last Update Posted: March 5, 2015
• Sponsor: University of Pennsylvania
• Collaborator: Abbott
• Information provided by (Responsible Party): University of Pennsylvania

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.

Condition or disease	Intervention/treatment	Phase
Flushing	Dietary Supplement: Quercetin; Dietary Supplement: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)
• Study Start Date: February 2009
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

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 Name: 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 Name: 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 Name: Isoquercetin
Placebo Comparator: Placebo; Placebo once, administered one hour before 500 mg immediate-release niacin	Dietary Supplement: Placebo; Placebo PO one time

Outcome Measures

Primary Outcome Measures :

1. Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin [ Time Frame: 8 hour period ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Pennsylvania

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

Phila, Pennsylvania, United States, 19104

University of Pennsylvania

Phila, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Abbott

Investigators

• Principal Investigator: Richard L. Dunbar, MD; University of Pennsylvania

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00913081
• Other Study ID Numbers: IRB #808911
• First Posted: June 3, 2009
• Results First Posted: March 5, 2015
• Last Update Posted: March 5, 2015
• Last Verified: November 2011

Keywords provided by University of Pennsylvania:

Skin; pharmacology; metabolism; lipid

Additional relevant MeSH terms:

Flushing; Skin Manifestations; Quercetin; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs