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CompletedNCT03650140Updated Jan 9, 2023

Pharmacokinetics and Pharmacodynamics of Anthocyanins

An interventional study of Tart cherry extract 60 mL and Tart cherry extract 120 mL in Gout, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-09.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gout

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Keywords

  • Gout
  • Tart Cherry
  • Pharmacokinetics
03

In context

Gout

232 studies on the registry are indexed under Gout; 45 are open to participants now.

This study's enrollment of 10 is below the median of 121 across 202 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of gout

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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 · Dietary Supplement: Tart cherry extract 120 mL

  • 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 · Dietary Supplement: Tart cherry extract 120 mL

Interventions

  • Dietary supplementTart cherry extract 60 mL

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

  • Dietary supplementTart cherry extract 120 mL

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

06

What researchers measure

Primary outcomes

  1. Highly sensitive C-reactive protein (hs-CRP)

    Reduction in hs-CRP

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

Secondary outcomes

  1. Area under the curve (AUC)

    The area under the plasma anthocyanin concentration-time curve

    Time frame: Through study completion (during the 12 hours after a dose)

  2. Change in inflammatory marker expression

    Fold change in mRNA expression of Nrf2

    Time frame: Through study completion (during the 12 hours after a dose)

  3. Peak plasma concentration (Cmax)

    Peak plasma concentration of anthocyanins

    Time frame: Through study completion (during the 12 hours after a dose)

  4. Time to peak plasma concentration (Tmax)

    Time to achieve peak plasma anthocyanin concentration

    Time frame: Through study completion (during the 12 hours after a dose)

  5. Half-life (t1/2)

    Plasma anthocyanin half-life

    Time frame: Through study completion (during the 12 hours after a dose)

07

Study locations

1 site
  • Robert Wood Johnson Medical School
    New Brunswick, New Jersey 08901, United States
08

References and documents

Study documents

  • Informed consent form · Jun 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03650140
Lead sponsor
Rutgers, The State University of New Jersey
Responsible party
Naomi Schlesinger, MD, Professor of Medicine (Professor of Medicine, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Aug 28, 2018
Start date
Feb 1, 2019
Primary completion
Jun 1, 2022
Completion
Jun 6, 2022
Last update
Jan 9, 2023

Study contacts

Naomi Schlesinger, MD
principal investigator · Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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