Montmorency Cherry Juice and Uric Acid Metabolism

Inflammation Clinical Trial

Official title:

The Influence of Tart Montmorency Cherries on Indices of Uric Acid Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825070
• Other study ID #: RE10-01-12554
• Secondary ID: 914
• Status: Completed
• Phase: N/A
• First received: March 29, 2013
• Last updated: April 2, 2013
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee Northumbria University
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• apparently healthy males/females between the ages of 18-40 years

Exclusion Criteria:

• underlying clinical pathology

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Inflammation

Intervention

Dietary Supplement:
• Montmorency cherry concentrate
Tart Montmorency cherry juice concentrate

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in anthocyanins, polyphenolics and creatinine	measurement of changes in anthocyanins, polyphenolics and creatinine over a 48h period	0,1,2,3,5,8,24,26,48 hours	No
Primary	Change in uric acid	measurement of changes in uric acid over a 48h period	0, 1, 2, 3, 5, 8, 24, 26, 48 hours	No
Secondary	Change in C-reactive protein	measurement of changes in c-reative protein over a 48h period	0,1,2,3,5,8,24,26,48 hours	No