Gout
Conditions
Keywords
Gout, Tart Cherry, Pharmacokinetics
Brief summary
The purpose of the study is to establish the pharmacokinetic parameters of cherry juice concentrate and identify its potential to alter inflammatory markers in gout patients.
Interventions
DIETARY_SUPPLEMENTTart cherry extract 60 mL
Subjects will receive a single 60 mL oral dose of tart cherry extract.
DIETARY_SUPPLEMENTTart cherry extract 120 mL
Subjects will receive a single 120 mL oral dose of tart cherry extract.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of gout
Exclusion criteria
* Allergy to cherries or cherry products * Any history of malignancy * History of any pancreatic or biliary tract disease * Significant Anemia * History of significant renal (sCr \> 1.5 mg/dL) * Hepatic disease (liver enzymes 3 times upper limit of normal) * Any active gastrointestinal condition * History of large bowel resection for any reason * Use of cherry juice concentrate or consumption of cherries within 14 days * Personal or inherited bleeding disorders or currently on anticoagulation * Women of childbearing age not on oral contraceptives * Women who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Highly sensitive C-reactive protein (hs-CRP) | Maximal change in hs-CRP from baseline through study completion (during the 12 hours after a dose) | Reduction in hs-CRP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) | Through study completion (during the 12 hours after a dose) | The area under the plasma anthocyanin concentration-time curve |
| Change in inflammatory marker expression | Through study completion (during the 12 hours after a dose) | Fold change in mRNA expression of Nrf2 |
| Peak plasma concentration (Cmax) | Through study completion (during the 12 hours after a dose) | Peak plasma concentration of anthocyanins |
| Time to peak plasma concentration (Tmax) | Through study completion (during the 12 hours after a dose) | Time to achieve peak plasma anthocyanin concentration |
| Half-life (t1/2) | Through study completion (during the 12 hours after a dose) | Plasma anthocyanin half-life |
Countries
United States
Outcome results
None listed