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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03650140
Other study ID # Pro20170001180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date June 6, 2022

Study information

Verified date January 2023
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 6, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Tart cherry extract 60 mL
Subjects will receive a single 60 mL oral dose of tart cherry extract.
Tart cherry extract 120 mL
Subjects will receive a single 120 mL oral dose of tart cherry extract.

Locations

Country Name City State
United States Robert Wood Johnson Medical School New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

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