Pharmacokinetics and Pharmacodynamics of Anthocyanins

Gout Clinical Trial

Official title:

PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650140
• Other study ID #: Pro20170001180
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gout

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)