Pharmacokinetics and Pharmacodynamics of Anthocyanins

Rutgers The State University of New Jersey

Status: Completed

Conditions: Gout

Treatments: Dietary Supplement: Tart cherry extract 120 mL; Dietary Supplement: Tart cherry extract 60 mL

Study type: Interventional

Funder types: Other

Identifiers

NCT03650140

Pro20170001180

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Tart cherry concentrate 60 mL

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Tart cherry extract 60 mL

Dietary Supplement: Tart cherry extract 120 mL

Tart cherry concentrate 120 mL

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Tart cherry extract 60 mL

Dietary Supplement: Tart cherry extract 120 mL