Trial Outcomes & Findings for Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States (NCT NCT01722669)
NCT ID: NCT01722669
Last Updated: 2020-10-12
Results Overview
AUC 0-24 hours of measured plasma quercetin aglycone for Arms A1, B1, A2, B2, C Collected at timepoints: baseline and 1, 2, 4, 6, 8, and 24 hours after dose. PK and PDI samples were not measured for Arm D (anti-phospholipid antibody cohort)
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
38 participants
Primary outcome timeframe
24 hours
Results posted on
2020-10-12
Participant Flow
Participant milestones
| Measure |
Quercetin 500mg (ARM A1)
Single dose PK/PD analyses of quercetin 500 mg
|
Isoquercetin 500mg (ARM B1)
Single dose PK/PD of isoquercetin 500 mg
|
Quercetin 500 mg + Ascorbic Acid (ARM A2)
Single dose quercetin with 500 mg + ascorbic acid pk/pd analyses
|
Isoquercetin 500 mg + Ascorbic Acid (ARM B2)
Single dose isoquercetin 500 mg + ascorbic acid pk/pd analyses
|
Isoquercetin 1000 mg + Ascorbic Acid (ARM C)
Single dose isoquercetin + 1000 mg ascorbic acid
|
Antiphospholipid Antibody Cohort (ARM D)
Single dose isoquercetin 1000 mg + 1000 mg ascorbic acid in patients with antiphospholipid antibodies
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
10
|
8
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Quercetin 500mg (ARM A1)
Single dose PK/PD analyses of quercetin 500 mg
|
Isoquercetin 500mg (ARM B1)
Single dose PK/PD of isoquercetin 500 mg
|
Quercetin 500 mg + Ascorbic Acid (ARM A2)
Single dose quercetin with 500 mg + ascorbic acid pk/pd analyses
|
Isoquercetin 500 mg + Ascorbic Acid (ARM B2)
Single dose isoquercetin 500 mg + ascorbic acid pk/pd analyses
|
Isoquercetin 1000 mg + Ascorbic Acid (ARM C)
Single dose isoquercetin + 1000 mg ascorbic acid
|
Antiphospholipid Antibody Cohort (ARM D)
Single dose isoquercetin 1000 mg + 1000 mg ascorbic acid in patients with antiphospholipid antibodies
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
Baseline characteristics by cohort
| Measure |
Quercetin 500 mg (ARM A1)
n=5 Participants
Single dose of quercetin PK/PD analysis
|
Isoquercetin 500 mg (ARM B1)
n=5 Participants
Single dose of isoquercetin PK/PD analysis
|
Quercetin 500 mg + Ascorbic Acid (ARM A2)
n=5 Participants
Single dose of quercetin + ascorbic acid PK/PD analysis
|
Isoquercetin 500 mg + Ascorbic Acid (ARM B2)
n=5 Participants
Single dose of isqouercetin +ascorbic acid PK/PD analysis
|
Isoquercetin 1000 mg + Ascorbic Acid (ARM C)
n=10 Participants
single dose isoquercetin + ascorbic acid PK/PD analyses
|
Antiphospholipid Antibody (ARM D)
n=6 Participants
single dose isoquercetin +ascorbic acid in patients with antiphospholipid antibodies
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
10 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
4 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
34 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
3 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
3 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
20 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
3 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
16 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
6 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
17 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
4 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
3 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
4 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
3 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
17 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
3 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
5 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
18 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=7 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
1 Participants
n=5 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
2 Participants
n=4 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
4 Participants
n=21 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
0 Participants
n=10 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
10 Participants
n=115 Participants • Antiphospholipid Antibody (ARM D): 2 withdrew consent without data collected
|
PRIMARY outcome
Timeframe: 24 hoursAUC 0-24 hours of measured plasma quercetin aglycone for Arms A1, B1, A2, B2, C Collected at timepoints: baseline and 1, 2, 4, 6, 8, and 24 hours after dose. PK and PDI samples were not measured for Arm D (anti-phospholipid antibody cohort)
Outcome measures
| Measure |
Quercetin 500 mg (ARM A1)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 500 mg (ARM B1)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Quercetin 500 mg + Ascorbic Acid (ARM A2)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 500 mg + Ascorbic Acid (ARM B2)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 1000 mg + Ascorbic Acid (ARM C)
n=10 Participants
Single dose, measurement of plasma quercetin aglycone
|
|---|---|---|---|---|---|
|
AUC
|
4.78 uM hr/L
Standard Deviation 1.67
|
15.00 uM hr/L
Standard Deviation 8.94
|
5.41 uM hr/L
Standard Deviation 2.13
|
16.34 uM hr/L
Standard Deviation 10.08
|
40.3 uM hr/L
Standard Deviation 17.11
|
SECONDARY outcome
Timeframe: 2 hours. Not measured in DPopulation: 2 hours after oral ingestion
Measurement of protein disulfide inhibition in plasma using a fluorescent PDI substrate (dieosin glutathione disulfide)
Outcome measures
| Measure |
Quercetin 500 mg (ARM A1)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 500 mg (ARM B1)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Quercetin 500 mg + Ascorbic Acid (ARM A2)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 500 mg + Ascorbic Acid (ARM B2)
n=5 Participants
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 1000 mg + Ascorbic Acid (ARM C)
n=10 Participants
Single dose, measurement of plasma quercetin aglycone
|
|---|---|---|---|---|---|
|
Reductase Activity of PDI Using Dieosin Glutathione Disulfide
|
31.9 Percent inhibition
Standard Deviation 24.14
|
63.2 Percent inhibition
Standard Deviation 25.3
|
16 Percent inhibition
Standard Deviation 31.8
|
8.3 Percent inhibition
Standard Deviation 15.03
|
38 Percent inhibition
Standard Deviation 35
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: 4 hours after single dose only measured in Arm C and Arm D
Thrombin induced thrombin generation measured in patient plasma
Outcome measures
| Measure |
Quercetin 500 mg (ARM A1)
n=10 Participants
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 500 mg (ARM B1)
n=6 Participants
Single dose, measurement of plasma quercetin aglycone
|
Quercetin 500 mg + Ascorbic Acid (ARM A2)
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 500 mg + Ascorbic Acid (ARM B2)
Single dose, measurement of plasma quercetin aglycone
|
Isoquercetin 1000 mg + Ascorbic Acid (ARM C)
Single dose, measurement of plasma quercetin aglycone
|
|---|---|---|---|---|---|
|
Platelet-induced Thrombin Generation (U/mL)
|
0.30 U/mL
Standard Deviation .28
|
1.40 U/mL
Standard Deviation 2.14
|
—
|
—
|
—
|
Adverse Events
Quercetin 500 mg (ARM A1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Isoquercetin 500 mg (ARM B1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Quercetin 500 mg + Ascorbic Acid (ARM A2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Isoquercetin 500 mg + Ascorbic Acid (ARM B2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Isoquercetin 1000 mg + Ascorbic Acid (ARM C)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antiphospholipid Antibody (ARM D)
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
Jeffrey Zwicker, Division of Thrombosis and Haemostasis, Division of Hematology and Oncology
Beth Israel Deaconess Medical Center, Harvard Medical School
Phone: 617-667-9299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place