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Pharmacokinetics and Pharmacodynamics of Anthocyanins

Primary Purpose

Gout

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tart cherry extract 60 mL

Tart cherry extract 120 mL

About this trial

This is an interventional other trial for Gout focused on measuring Gout, Tart Cherry, Pharmacokinetics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tart cherry concentrate 60 mL

Tart cherry concentrate 120 mL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Highly sensitive C-reactive protein (hs-CRP)

Reduction in hs-CRP

Secondary Outcome Measures

Area under the curve (AUC)

The area under the plasma anthocyanin concentration-time curve

Change in inflammatory marker expression

Fold change in mRNA expression of Nrf2

Peak plasma concentration (Cmax)

Peak plasma concentration of anthocyanins

Time to peak plasma concentration (Tmax)

Time to achieve peak plasma anthocyanin concentration

Half-life (t1/2)

Plasma anthocyanin half-life

Full Information

NCT ID

NCT03650140

First Posted

August 13, 2018

Last Updated

January 5, 2023

Sponsor

Rutgers, The State University of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT03650140

Brief Title

Pharmacokinetics and Pharmacodynamics of Anthocyanins

Official Title

PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gout

Keywords

Gout, Tart Cherry, Pharmacokinetics

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tart cherry concentrate 60 mL

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Tart cherry concentrate 120 mL

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Tart cherry extract 60 mL

Intervention Description

Subjects will receive a single 60 mL oral dose of tart cherry extract.

Intervention Type

Dietary Supplement

Intervention Name(s)

Tart cherry extract 120 mL

Intervention Description

Subjects will receive a single 120 mL oral dose of tart cherry extract.

Primary Outcome Measure Information:

Title

Highly sensitive C-reactive protein (hs-CRP)

Description

Reduction in hs-CRP

Time Frame

Maximal change in hs-CRP from baseline through study completion (during the 12 hours after a dose)

Secondary Outcome Measure Information:

Title

Area under the curve (AUC)

Description

The area under the plasma anthocyanin concentration-time curve

Time Frame