- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01825070
Montmorency Cherry Juice and Uric Acid Metabolism
The Influence of Tart Montmorency Cherries on Indices of Uric Acid Metabolism
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tyne and Wear
-
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Northumbria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- apparently healthy males/females between the ages of 18-40 years
Exclusion Criteria:
- underlying clinical pathology
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: low dose
Montmorency cherry concentrate, 30 mls
|
Tart Montmorency cherry juice concentrate
|
Experimental: higher dose
Montmorency cherry concentrate, 60 mls
|
Tart Montmorency cherry juice concentrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0, 1, 2, 3, 5, 8, 24, 26, 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in C-reactive protein
Time Frame: 0,1,2,3,5,8,24,26,48 hours
|
measurement of changes in c-reative protein over a 48h period
|
0,1,2,3,5,8,24,26,48 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anthocyanins, polyphenolics and creatinine
Time Frame: 0,1,2,3,5,8,24,26,48 hours
|
measurement of changes in anthocyanins, polyphenolics and creatinine over a 48h period
|
0,1,2,3,5,8,24,26,48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RE10-01-12554
- 914 (Northumbria University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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