Pharmacokinetics and Pharmacodynamics of Anthocyanins

NCT ID: NCT03650140

Last Updated: 2023-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-06-06

Brief Summary

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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

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Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Tart cherry extract 60 mL

Intervention Type DIETARY_SUPPLEMENT

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

Tart cherry extract 120 mL

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type ACTIVE_COMPARATOR

Tart cherry extract 60 mL

Intervention Type DIETARY_SUPPLEMENT

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

Tart cherry extract 120 mL

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Tart cherry extract 60 mL

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

Intervention Type DIETARY_SUPPLEMENT

Tart cherry extract 120 mL

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Naomi Schlesinger, MD, Professor of Medicine

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naomi Schlesinger, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center

Locations

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Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro20170001180

Identifier Type: -

Identifier Source: org_study_id

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