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OpenTrials
Completed

NCT Number: NCT03650140

Pharmacokinetics and Pharmacodynamics of Anthocyanins

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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tart cherry extract 60 mL

Dietary Supplement

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

Tart cherry extract 120 mL

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2018
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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