Pharmacokinetics and Pharmacodynamics of Anthocyanins

Study Overview
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Brief Summary
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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.

Official Title
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PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients

Conditions
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Gout

Intervention / Treatment
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* Dietary Supplement: Tart cherry extract 60 mL
* Dietary Supplement: Tart cherry extract 120 mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tart cherry concentrate 60 mL<br>Subjects will receive a single oral dose of 60 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 120 mL dose group. | Dietary Supplement: Tart cherry extract 60 mL<br>* Subjects will receive a single 60 mL oral dose of tart cherry extract.<br>Dietary Supplement: Tart cherry extract 120 mL<br>* Subjects will receive a single 120 mL oral dose of tart cherry extract.<br>|
| Active Comparator: Tart cherry concentrate 120 mL<br>Subjects will receive a single oral dose of 120 mL tart cherry concentrate. After a 2 week wash-out subjects will cross over into the 60 mL dose group. | Dietary Supplement: Tart cherry extract 60 mL<br>* Subjects will receive a single 60 mL oral dose of tart cherry extract.<br>Dietary Supplement: Tart cherry extract 120 mL<br>* Subjects will receive a single 120 mL oral dose of tart cherry extract.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highly sensitive C-reactive protein (hs-CRP) | Reduction in hs-CRP | Maximal change in hs-CRP from baseline through study completion (during the 12 hours after a dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) | The area under the plasma anthocyanin concentration-time curve | Through study completion (during the 12 hours after a dose) | 
| Change in inflammatory marker expression | Fold change in mRNA expression of Nrf2 | Through study completion (during the 12 hours after a dose) | 
| Peak plasma concentration (Cmax) | Peak plasma concentration of anthocyanins | Through study completion (during the 12 hours after a dose) | 
| Time to peak plasma concentration (Tmax) | Time to achieve peak plasma anthocyanin concentration | Through study completion (during the 12 hours after a dose) | 
| Half-life (t1/2) | Plasma anthocyanin half-life | Through study completion (during the 12 hours after a dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout, Tart Cherry, Pharmacokinetics