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Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00913081
First received: May 29, 2009
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Flushing
 Dietary Supplement: Quercetin
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)

Resource links provided by NLM:

Drug Information available for: Niacin
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Aim 1 is to assess whether the flavonoid quercetin inhibits niacin-induced flushing in a dose-responsive fashion and compared to placebo. [ Time Frame: 8 hour period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aim 2 is to assess whether the flushing inhibition with quercetin enhances the anti-lipolytic benefit of niacin in a dose-responsive fashion and compared to placebo. Subjects will be monitored over an 8 hour period. [ Time Frame: 8 hour period ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: February 2009
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quercetin 500 mg Dietary Supplement: Quercetin
Quercetin 500, 1000, or 2000 mg PO one time
Other Name: Isoquercetin
Experimental: Quercetin 1000 mg Dietary Supplement: Quercetin
Quercetin 500, 1000, or 2000 mg PO one time
Other Name: Isoquercetin
Experimental: Quercetin 2000 mg Dietary Supplement: Quercetin
Quercetin 500, 1000, or 2000 mg PO one time
Other Name: Isoquercetin
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo PO one time

Detailed Description:

This study involves people between 21 and 75 years. It will 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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913081

Locations
United States, Pennsylvania
University of Pennsylvania
Phila, Pennsylvania, United States, 19104
CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor
Phila, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Abbott
Investigators
Principal Investigator: Richard L. Dunbar, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00913081     History of Changes
Other Study ID Numbers: IRB #808911
Study First Received: May 29, 2009
Last Updated: November 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Skin
pharmacology
metabolism
lipid

Additional relevant MeSH terms:
Flushing
Signs and Symptoms
Quercetin
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013