Pharmacokinetics and Pharmacodynamics of Anthocyanins

Not Applicable

Completed

• Conditions: Gout
• Interventions: Dietary Supplement: Tart cherry extract 60 mL; Dietary Supplement: Tart cherry extract 120 mL

• Registration Number: NCT03650140
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-25
• Study First Posted: 2018-08-28
• Study Start: 2019-02-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tart cherry concentrate 120 mL	Tart cherry extract 120 mL	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.
Tart cherry concentrate 60 mL	Tart cherry extract 120 mL	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.
Tart cherry concentrate 120 mL	Tart cherry extract 60 mL	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.
Tart cherry concentrate 60 mL	Tart cherry extract 60 mL	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change in inflammatory marker expression	Through study completion (during the 12 hours after a dose)	Fold change in mRNA expression of Nrf2
Half-life (t1/2)	Through study completion (during the 12 hours after a dose)	Plasma anthocyanin half-life
Area under the curve (AUC)	Through study completion (during the 12 hours after a dose)	The area under the plasma anthocyanin concentration-time curve

Trial Locations

Locations (1)

Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States