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Pharmacokinetics and Pharmacodynamics of Anthocyanins

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ClinicalTrials.gov Identifier: NCT03650140
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Naomi Schlesinger, MD, Professor of Medicine, 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.

Condition or disease Intervention/treatment Phase
Gout Dietary Supplement: Tart cherry extract 60 mL Dietary Supplement: Tart cherry extract 120 mL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

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.




Primary Outcome Measures :
  1. Highly sensitive C-reactive protein (hs-CRP) [ Time Frame: Maximal change in hs-CRP from baseline through study completion (during the 12 hours after a dose) ]
    Reduction in hs-CRP


Secondary Outcome Measures :
  1. Area under the curve (AUC) [ Time Frame: Through study completion (during the 12 hours after a dose) ]
    The area under the plasma anthocyanin concentration-time curve

  2. Change in inflammatory marker expression [ Time Frame: Through study completion (during the 12 hours after a dose) ]
    Fold change in mRNA expression of Nrf2

  3. Peak plasma concentration (Cmax) [ Time Frame: Through study completion (during the 12 hours after a dose) ]
    Peak plasma concentration of anthocyanins

  4. Time to peak plasma concentration (Tmax) [ Time Frame: Through study completion (during the 12 hours after a dose) ]
    Time to achieve peak plasma anthocyanin concentration

  5. Half-life (t1/2) [ Time Frame: Through study completion (during the 12 hours after a dose) ]
    Plasma anthocyanin half-life



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650140


Contacts
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Contact: Naomi Schlesinger, MD 732-235-7217 schlesna@rwjms.rutgers.edu

Locations
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United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Naomi Schlesinger, MD Rutgers, The State University of New Jersey

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Responsible Party: Naomi Schlesinger, MD, Professor of Medicine, Professor of Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03650140     History of Changes
Other Study ID Numbers: Pro20170001180
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naomi Schlesinger, MD, Professor of Medicine, Rutgers, The State University of New Jersey:
Gout
Tart Cherry
Pharmacokinetics