NCT01825070

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

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

Study Start

First participant enrolled

March 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

March 29, 2013

Last Update Submit

April 2, 2013

Conditions

Inflammation

Keywords

Montmorency tart cherriesInflammationUric acid

Outcome Measures

Primary Outcomes (1)

  • Change in uric acid

    measurement of changes in uric acid over a 48h period

    0, 1, 2, 3, 5, 8, 24, 26, 48 hours

Secondary Outcomes (1)

  • Change in C-reactive protein

    0,1,2,3,5,8,24,26,48 hours

Other Outcomes (1)

  • Change in anthocyanins, polyphenolics and creatinine

    0,1,2,3,5,8,24,26,48 hours

Study Arms (2)

low dose

EXPERIMENTAL

Montmorency cherry concentrate, 30 mls

Dietary Supplement: Montmorency cherry concentrate

higher dose

EXPERIMENTAL

Montmorency cherry concentrate, 60 mls

Dietary Supplement: Montmorency cherry concentrate

Interventions

Montmorency cherry concentrateDIETARY_SUPPLEMENT

Tart Montmorency cherry juice concentrate

higher doselow dose

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • underlying clinical pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Glyn Howatson, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 5, 2013

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Study Completion

March 1, 2013

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations

GB(1)