GoutNCT03650140
Pharmacokinetics and Pharmacodynamics of Anthocyanins
A study testing Tart cherry extract 60 mL and Tart cherry extract 120 mL in people with Gout, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gout
- What is being tested?
- Tart cherry extract 60 mL and Tart cherry extract 120 mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 6 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of gout
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients
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.
- Conditions
- Gout
- Being tested
- Tart cherry extract 60 mL, Tart cherry extract 120 mL
- Keywords
- Gout, Tart Cherry, Pharmacokinetics
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart cherry extract 60 mLDietary supplement
Subjects will receive a single 60 mL oral dose of tart cherry extract.
Tart cherry extract 120 mLDietary supplement
Subjects will receive a single 120 mL oral dose of tart cherry extract.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Tart cherry extract 60 mL; Dietary 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. Receives: Dietary Supplement: Tart cherry extract 60 mL; Dietary Supplement: Tart cherry extract 120 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highly sensitive C-reactive protein (hs-CRP)
Reduction in hs-CRP
Measured: 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)
The area under the plasma anthocyanin concentration-time curve
Measured: Through study completion (during the 12 hours after a dose)
Change in inflammatory marker expression
Fold change in mRNA expression of Nrf2
Measured: Through study completion (during the 12 hours after a dose)
Peak plasma concentration (Cmax)
Peak plasma concentration of anthocyanins
Measured: Through study completion (during the 12 hours after a dose)
Time to peak plasma concentration (Tmax)
Time to achieve peak plasma anthocyanin concentration
Measured: Through study completion (during the 12 hours after a dose)
Half-life (t1/2)
Plasma anthocyanin half-life
Measured: Through study completion (during the 12 hours after a dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Feb 2019
- Primary completion1 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Schlesinger, MD, Professor of Medicine, Rutgers, The State University of New Jersey
- Investigators
- Naomi Schlesinger, MD, Principal investigator, Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650140
- Sponsor's protocol ID
- Pro20170001180
- Status last verified
- Jan 2023
- First submitted
- 13 Aug 2018
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PKPD of Anthocyanins After Oral Cherry Juice Concentrate in Gout Patients
- ClinicalTrials.gov ID
- NCT03650140
- Acronym / sponsor ID
- Pro20170001180
- Conditions
- Gout
- Keywords
- Gout, Tart Cherry, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tart cherry concentrate 60 mL | Active comparator | Dietary Supplement: Tart cherry extract 60 mL, Dietary Supplement: Tart cherry extract 120 mLSubjects 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. |
| Tart cherry concentrate 120 mL | Active comparator | Dietary Supplement: Tart cherry extract 60 mL, Dietary Supplement: Tart cherry extract 120 mLSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of gout
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tart cherry extract 60 mLSubjects will receive a single 60 mL oral dose of tart cherry extract. | Dietary supplement | Tart cherry concentrate 120 mL, Tart cherry concentrate 60 mL |
| Tart cherry extract 120 mLSubjects will receive a single 120 mL oral dose of tart cherry extract. | Dietary supplement | Tart cherry concentrate 120 mL, Tart cherry concentrate 60 mL |
Primary outcome
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
5 secondary outcomes
Area under the curve (AUC)
Time frame: Through study completion (during the 12 hours after a dose)
Change in inflammatory marker expression
Time frame: Through study completion (during the 12 hours after a dose)
Peak plasma concentration (Cmax)
Time frame: Through study completion (during the 12 hours after a dose)
Time to peak plasma concentration (Tmax)
Time frame: Through study completion (during the 12 hours after a dose)
Half-life (t1/2)
Time frame: Through study completion (during the 12 hours after a dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Schlesinger, MD principal investigator
Robert Wood Johnson Medical School/ Rutgers RWJMS Gout Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tart cherry extract 60 mL and Tart cherry extract 120 mL in people with Gout, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.