Pharmacokinetics and Pharmacodynamics of Anthocyanins

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Suspended

CT.gov ID

NCT03650140

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gout	Dietary Supplement: Tart cherry extract 60 mL Dietary Supplement: Tart cherry extract 120 mL	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

Principal Investigator: Naomi Schlesinger, MD, Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naomi Schlesinger, MD, Professor of Medicine, Professor of Medicine, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT03650140

Other Study ID Numbers:

Pro20170001180

First Posted:

Aug 28, 2018

Last Update Posted:

May 12, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Naomi Schlesinger, MD, Professor of Medicine, Professor of Medicine, Rutgers, The State University of New Jersey

Gout

Tart Cherry

Pharmacokinetics

Additional relevant MeSH terms:

Gout

Study Results

No Results Posted as of May 12, 2021