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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quercetin 500 mg | Experimental | Quercetin 500 mg once, administered one hour before 500 mg immediate-release niacin |
|
| Quercetin 1000 mg | Experimental | Quercetin 1000 mg once, administered one hour before 500 mg immediate-release niacin |
|
| Quercetin 2000 mg | Experimental | Quercetin 2000 mg once, administered one hour before 500 mg immediate-release niacin |
|
| Placebo | Placebo Comparator | Placebo once, administered one hour before 500 mg immediate-release niacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quercetin | Dietary Supplement | Quercetin 500, 1000, or 2000 mg PO one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L. Dunbar, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor | Philadelphia | Pennsylvania | 19104 | United States | ||
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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Quercetin 500 mg + Niacin 500 mg (1day) |
| |||||||||||||
| Washout #1 (7 Days) |
| |||||||||||||
| Quercetin 1000 mg + Niacin 500 mg (1day) |
| |||||||||||||
| Washout #2 (7 Days) |
| |||||||||||||
| Quercetin 2000 mg + Niacin 500 mg (1day) |
| |||||||||||||
| Washout #3 (7days) |
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| Placebo + Niacin 500 mg (1day) |
|
All study participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects who finished at least one visit were analysed. | Posted | Mean | 95% Confidence Interval | Fold change over baseline | 8 hour period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quercetin 500 mg | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard L. Dunbar, MD, PI | University of Pennsylvania | 609 413-1067 | richard.dunbar@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D005483 | Flushing |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011794 | Quercetin |
| C016527 | isoquercitrin |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Placebo | Dietary Supplement | Placebo PO one time |
|
| University of Pennsylvania |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Quercetin 1000 mg | 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. |
| OG002 | Quercetin 2000 mg | 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. |
| OG003 | Placebo | 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. |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Quercetin 1000 mg | 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. | 0 | 17 | 0 | 17 |
| EG002 | Quercetin 2000 mg | 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. | 0 | 17 | 0 | 17 |
| EG003 | Placebo | 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. | 0 | 17 | 0 | 17 |
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| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |