NCT03650140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

3.3 years

First QC Date

August 13, 2018

Last Update Submit

January 5, 2023

Conditions

Gout

Keywords

GoutTart CherryPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Highly sensitive C-reactive protein (hs-CRP)

    Reduction in hs-CRP

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

Secondary Outcomes (5)

  • Area under the curve (AUC)

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

  • Change in inflammatory marker expression

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

  • Peak plasma concentration (Cmax)

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

  • Time to peak plasma concentration (Tmax)

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

  • Half-life (t1/2)

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

Study Arms (2)

Tart cherry concentrate 60 mL

ACTIVE COMPARATOR

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 mLDietary Supplement: Tart cherry extract 120 mL

Tart cherry concentrate 120 mL

ACTIVE COMPARATOR

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 mLDietary Supplement: Tart cherry extract 120 mL

Interventions

Tart cherry extract 60 mLDIETARY_SUPPLEMENT

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

Tart cherry concentrate 120 mLTart cherry concentrate 60 mL
Tart cherry extract 120 mLDIETARY_SUPPLEMENT

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

Tart cherry concentrate 120 mLTart cherry concentrate 60 mL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of gout

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Naomi Schlesinger, MD

    Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 28, 2018

Study Start

February 1, 2019

Primary Completion

June 1, 2022

Study Completion

June 6, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)