Pharmacokinetics and Pharmacodynamics of Anthocyanins

PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients

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.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Dietary supplement: Tart cherry extract 60 mL; Dietary supplement: Tart cherry extract 120 mL

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tart cherry concentrate 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.	Dietary supplement: Tart cherry extract 60 mL; Subjects will receive a single 60 mL oral dose of tart cherry extract.; Dietary supplement: Tart cherry extract 120 mL; Subjects will receive a single 120 mL oral dose of tart cherry extract.
Active Comparator: Tart cherry concentrate 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.	Dietary supplement: Tart cherry extract 60 mL; Subjects will receive a single 60 mL oral dose of tart cherry extract.; Dietary supplement: Tart cherry extract 120 mL; Subjects will receive a single 120 mL oral dose of tart cherry extract.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Naomi Schlesinger, MD, Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 25, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Gout; Tart Cherry
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
• Other Study ID Numbers: Pro20170001180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No