- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532622
Impact of Blueberries on Uric Acid and Quality of Life
October 18, 2013 updated by: Daniel Riche, University of Mississippi Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 86 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- Uric acid > 6.0 mg/dL
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Blueberry Powder
Patients will take 30 grams of blueberry powder daily for up to 30 days.
|
Patients will take 30 grams of blueberry powder daily for up to 30 days
Other Names:
|
Placebo Comparator: Placebo Powder
Patients will take 30 grams of placebo powder daily for up to 30 days.
|
Patients will take 30 grams of placebo powder daily for up to 30 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline and Placebo in Uric Acid Level in Patients Randomized to Treatment Group
Time Frame: Baseline, ~30 days later
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure
Time Frame: Baseline, ~30 days, ~45 days, ~75 days
|
Percent change and absolute change of blood pressure from baseline and placebo
|
Baseline, ~30 days, ~45 days, ~75 days
|
Body Weight
Time Frame: Baseline, ~30 days, ~45 days, ~75 days
|
Percent change and absolute change of body weight from baseline and placebo
|
Baseline, ~30 days, ~45 days, ~75 days
|
Quality of Life
Time Frame: Baseline, ~30 days, ~45 days, ~75 days
|
Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI)
|
Baseline, ~30 days, ~45 days, ~75 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
January 30, 2012
First Submitted That Met QC Criteria
February 13, 2012
First Posted (Estimate)
February 14, 2012
Study Record Updates
Last Update Posted (Estimate)
October 22, 2013
Last Update Submitted That Met QC Criteria
October 18, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-0218
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.
Clinical Trials on Hyperuricemia
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Lingling Yu (103250)Wuhan Integrated Traditional Chinese and Western Medicine Hospital; Xianning...Recruiting
-
Sun Yat-sen UniversityRecruiting
-
China Medical University HospitalUnknownHyperuricemia, Anserine, PharmacokineticTaiwan
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Shanghai Institute Of Biological ProductsFirst Affiliated Hospital Bengbu Medical CollegeCompletedAsymptomatic HyperuricemiaChina
-
China Medical University HospitalUnknown"Hyperuricemia,Anserine"Taiwan
-
AstraZenecaContract Research Organization: USA; PAREXEL Early Phase Clinical Unit Baltimore and other collaboratorsCompletedAsymptomatic HyperuricemiaUnited States
-
University of MinnesotaCompleted
-
Hebei Medical UniversityCompletedHeart Failure, HyperuricemiaChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Completed
Clinical Trials on Blueberry Powder
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Duke UniversityU.S. Highbush Blueberry CouncilCompletedSedentary Lifestyle | Blood Pressure | Overweight and Obesity | Arterial StiffnessUnited States
-
University of ReadingNaurex, Inc, an affiliate of Allergan plcCompletedCognitive DeclineUnited Kingdom
-
Hiroshima UniversityAgricultural Producers' Cooperative Corporation Shinpo-enCompleted
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Northumbria UniversityCompletedCognitive Change | Blood Pressure | Vascular StiffnessUnited Kingdom
-
University of Colorado, DenverU.S. Highbush Blueberry CouncilRecruiting
-
University of Nebraska LincolnRush University Medical Center; University of NebraskaCompletedObesity | Circadian DysregulationUnited States
-
Colorado State UniversityU.S. Highbush Blueberry CouncilCompletedHypertension | Menopause | Endothelial Dysfunction | Elevated Blood PressureUnited States
-
University of ReadingWild Blueberry Association of North America (WBANA)CompletedMood | Cognition | AffectUnited Kingdom
-
Atlantic Food and Horticulture Research CenterDalhousie University; U.S. Highbush Blueberry CouncilCompleted
-
Brigham and Women's HospitalRecruitingBrain Injuries | Cognitive Decline | Nutrition, HealthyUnited States