InflammationNCT01825070
Montmorency Cherry Juice and Uric Acid Metabolism
A study testing Montmorency cherry concentrate in people with Inflammation, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Cherries have been show to possess the ability to reduce uric acid concentrations and inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds than other cherries and hence makes the expectation possible that Montmorency cherries will lower uric acid and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Montmorency cherry concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Mar 2013
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- apparently healthy males/females between the ages of 18-40 years
Who cannot join
- underlying clinical pathology
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Influence of Tart Montmorency Cherries on Indices of Uric Acid Metabolism
Cherries have been show to possess the ability to reduce uric acid concentrations and inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds than other cherries and hence makes the expectation possible that Montmorency cherries will lower uric acid and inflammation.
Read the detailed description
Plasma and urinary uric acid concentration, plasma phytochemical content and inflammatory biomarkers will be measured in order to elucidate the effects of an acute dose of tart cherry juice on indices related to the condition of gout.
Participants will be required to attend the laboratory at a range of time points over two periods of 96 hours, separated by a 7 day washout period, to provide blood samples. In order to provide a baseline sample, participants will attend the laboratory in the morning following an overnight fast and voiding of any urine. Following this participants will be given 30mls (30 mls provides 323 mg/380 µmol of anthocyanins) of tart cherry juice or placebo, diluted with 60 mls of water to consume within 10 minutes. Participants will be required to consume identical dosages of the supplement immediately prior to evening meals and breakfasts (or same time each morning following blood sampling if non-breakfast eater) over the next 96 hours. Further blood and urine samples will be collected at 1, 2, 3, 5, 8, 24, 26, 48, 50, 72, 74 and 96 hours and will require participants to return to the laboratory at each of these time points. Following the first period of supplementation participants will complete a 7 day washout period in which they will not be required to attend the laboratory. Following the washout period they will repeat the supplementation period consuming the supplement they did not receive during the first period.
- Conditions
- Inflammation
- Being tested
- Montmorency cherry concentrate
- Keywords
- Montmorency tart cherries, Inflammation, Uric acid
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montmorency cherry concentrateDietary supplement
Tart Montmorency cherry juice concentrate
| Study group | Role | What they receive |
|---|---|---|
| low dose | Experimental | Montmorency cherry concentrate, 30 mls Receives: Dietary Supplement: Montmorency cherry concentrate |
| higher dose | Experimental | Montmorency cherry concentrate, 60 mls Receives: Dietary Supplement: Montmorency cherry concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in uric acid
measurement of changes in uric acid over a 48h period
Measured: 0, 1, 2, 3, 5, 8, 24, 26, 48 hours
Secondary outcomes (1)
Change in C-reactive protein
measurement of changes in c-reative protein over a 48h period
Measured: 0,1,2,3,5,8,24,26,48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glyn Howatson, Northumbria University
- Investigators
- Glyn Howatson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825070
- Sponsor's protocol ID
- RE10-01-12554
- Other IDs
- 914
- Status last verified
- Apr 2013
- First submitted
- 29 Mar 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Tart Montmorency Cherries on Indices of Uric Acid Metabolism
- ClinicalTrials.gov ID
- NCT01825070
- Acronym / sponsor ID
- RE10-01-12554
- Conditions
- Inflammation
- Keywords
- Montmorency tart cherries, Inflammation, Uric acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Apr 2013 (estimated)
- 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.
Cherries have been show to possess the ability to reduce uric acid concentrations and inflammation. Tart Montmorency cherries possess a higher concentration of the plant compounds than other cherries and hence makes the expectation possible that Montmorency cherries will lower uric acid and inflammation.
Detailed description
Plasma and urinary uric acid concentration, plasma phytochemical content and inflammatory biomarkers will be measured in order to elucidate the effects of an acute dose of tart cherry juice on indices related to the condition of gout.
Participants will be required to attend the laboratory at a range of time points over two periods of 96 hours, separated by a 7 day washout period, to provide blood samples. In order to provide a baseline sample, participants will attend the laboratory in the morning following an overnight fast and voiding of any urine. Following this participants will be given 30mls (30 mls provides 323 mg/380 µmol of anthocyanins) of tart cherry juice or placebo, diluted with 60 mls of water to consume within 10 minutes. Participants will be required to consume identical dosages of the supplement immediately prior to evening meals and breakfasts (or same time each morning following blood sampling if non-breakfast eater) over the next 96 hours. Further blood and urine samples will be collected at 1, 2, 3, 5, 8, 24, 26, 48, 50, 72, 74 and 96 hours and will require participants to return to the laboratory at each of these time points. Following the first period of supplementation participants will complete a 7 day washout period in which they will not be required to attend the laboratory. Following the washout period they will repeat the supplementation period consuming the supplement they did not receive during the first period.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose | Experimental | Dietary Supplement: Montmorency cherry concentrateMontmorency cherry concentrate, 30 mls |
| higher dose | Experimental | Dietary Supplement: Montmorency cherry concentrateMontmorency cherry concentrate, 60 mls |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- apparently healthy males/females between the ages of 18-40 years
Key exclusion criteria (1 listed)
- underlying clinical pathology
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 |
|---|---|---|
| Montmorency cherry concentrateTart Montmorency cherry juice concentrate | Dietary supplement | higher dose, low dose |
Primary outcome
Change in uric acid
Time frame: 0, 1, 2, 3, 5, 8, 24, 26, 48 hours
measurement of changes in uric acid over a 48h period
1 secondary outcome
Change in C-reactive protein
Time frame: 0,1,2,3,5,8,24,26,48 hours
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 5 Apr 2013.
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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.
Glyn Howatson, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montmorency cherry concentrate in people with Inflammation, run by Northumbria University at 1 site in United Kingdom.
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 1 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 5 Apr 2013. 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 Kingdom. 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?
Change in uric acid (time frame: 0, 1, 2, 3, 5, 8, 24, 26, 48 hours). 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 5 Apr 2013.