Impact of Blueberries on Uric Acid and Quality of Life
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to determine the impact of blueberries on uric acid in patients with hyperuricemia that are not receiving uric acid pharmacotherapy. The central hypothesis the investigators propose is that daily blueberries added to a pre-existing diet will promote uric acid lowering and improve quality of life without detriment to vital signs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 22, 2013
October 1, 2013
1.8 years
January 30, 2012
October 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline and Placebo in Uric Acid Level in Patients Randomized to Treatment Group
Percent change in uric acid level from baseline after 30 days of treatment with blueberry powder. Since this is designed as a crossover trial, baseline could represent uric acid level at the beginning of the study or after at least a 2-week washout period following placebo administration.
Baseline, ~30 days later
Secondary Outcomes (3)
Blood Pressure
Baseline, ~30 days, ~45 days, ~75 days
Body Weight
Baseline, ~30 days, ~45 days, ~75 days
Quality of Life
Baseline, ~30 days, ~45 days, ~75 days
Study Arms (2)
Blueberry Powder
ACTIVE COMPARATORPatients will take 30 grams of blueberry powder daily for up to 30 days.
Placebo Powder
PLACEBO COMPARATORPatients will take 30 grams of placebo powder daily for up to 30 days.
Interventions
Patients will take 30 grams of blueberry powder daily for up to 30 days
Patients will take 30 grams of placebo powder daily for up to 30 days.
Eligibility Criteria
You may qualify if:
- years or older
- Uric acid \> 6.0 mg/dL
You may not qualify if:
- Current moderate-to-severe symptomatic gout
- Currently receiving gout pharmacotherapy
- Current participation in another clinical trial
- Documented non-compliance or consistent missed appointments
- Women who are pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Riche, Pharm.D.
University of Mississippi Medical Center
- PRINCIPAL INVESTIGATOR
Marion Wofford, M.D., M.P.H.
University of Mississippi Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 14, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 22, 2013
Record last verified: 2013-10