Trial Outcomes & Findings for Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH) (NCT NCT00913081)

NCT ID: NCT00913081

Last Updated: 2015-03-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 17 participants
• Primary outcome timeframe: 8 hour period
• Results posted on: 2015-03-05

Participant Flow

The study enrolled healthy volunteers aged 21 to 75 years. Subjects were recruited at the University of Pennsylvania CTRC following a screening visit to confirm eligibility based on an interview reviewing their health status and medication use, baseline laboratory assessment and the ability to tolerate a 500 mg dose of immediate-release niacin

Subjects meeting inclusion criteria, able to tolerate 500mg of immediate-release niacin and to provide informed consent were randomized to one of the four study groups. First experimental visit was within 12 weeks of screening visit.

Participant milestones

Measure	All Study Participants Participants received one dose of Quercetin 500 mg, Quercetin 100 mg, Quercetin 200 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and pharmacodymic assessments for 8 hours after Quercetin dosing. Each participant then crossed over to one of the remaining dose group/placebo in a randomized, double blind fashion after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
Quercetin 500 mg + Niacin 500 mg (1day) STARTED	17
Quercetin 500 mg + Niacin 500 mg (1day) COMPLETED	17
Quercetin 500 mg + Niacin 500 mg (1day) NOT COMPLETED	0
Washout #1 (7 Days) STARTED	17
Washout #1 (7 Days) COMPLETED	17
Washout #1 (7 Days) NOT COMPLETED	0
Quercetin 1000 mg + Niacin 500 mg (1day) STARTED	17
Quercetin 1000 mg + Niacin 500 mg (1day) COMPLETED	17
Quercetin 1000 mg + Niacin 500 mg (1day) NOT COMPLETED	0
Washout #2 (7 Days) STARTED	17
Washout #2 (7 Days) COMPLETED	17
Washout #2 (7 Days) NOT COMPLETED	0
Quercetin 2000 mg + Niacin 500 mg (1day) STARTED	17
Quercetin 2000 mg + Niacin 500 mg (1day) COMPLETED	17
Quercetin 2000 mg + Niacin 500 mg (1day) NOT COMPLETED	0
Washout #3 (7days) STARTED	17
Washout #3 (7days) COMPLETED	17
Washout #3 (7days) NOT COMPLETED	0
Placebo + Niacin 500 mg (1day) STARTED	17
Placebo + Niacin 500 mg (1day) COMPLETED	17
Placebo + Niacin 500 mg (1day) NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)

Baseline characteristics by cohort

Measure	All Study Participants n=17 Participants Participants received one dose of Quercetin 500 mg, Quercetin 1000 mg, Quercetin 2000 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
Age, Continuous	38.1 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hour period

Population: All subjects who finished at least one visit were analysed.

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.

Outcome measures

Measure	Quercetin 500 mg n=17 Participants Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.	Quercetin 1000 mg n=17 Participants Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.	Quercetin 2000 mg n=17 Participants Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.	Placebo n=17 Participants Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin	9.9 Fold change over baseline Interval 7.0 to 13.0	9.4 Fold change over baseline Interval 6.0 to 12.0	7.7 Fold change over baseline Interval 5.0 to 11.0	8.9 Fold change over baseline Interval 6.0 to 12.0

Adverse Events

Quercetin 500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Quercetin 1000 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Quercetin 2000 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard L. Dunbar, MD, PI

University of Pennsylvania

Phone: 609 413-1067

Email: richard.dunbar@uphs.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place