Impact of Blueberries on Uric Acid and Quality of Life
Primary Purpose
Hyperuricemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry Powder
Placebo Powder
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia focused on measuring Blueberry
Eligibility Criteria
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
Sites / Locations
- University of Mississippi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Blueberry Powder
Placebo Powder
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Blood Pressure
Percent change and absolute change of blood pressure from baseline and placebo
Body Weight
Percent change and absolute change of body weight from baseline and placebo
Quality of Life
Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Full Information
NCT ID
NCT01532622
First Posted
January 30, 2012
Last Updated
October 18, 2013
Sponsor
University of Mississippi Medical Center
Collaborators
U.S. Highbush Blueberry Council
1. Study Identification
Unique Protocol Identification Number
NCT01532622
Brief Title
Impact of Blueberries on Uric Acid and Quality of Life
Official Title
Impact of Blueberries on Uric Acid and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
U.S. Highbush Blueberry Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
Keywords
Blueberry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blueberry Powder
Arm Type
Active Comparator
Arm Description
Patients will take 30 grams of blueberry powder daily for up to 30 days.
Arm Title
Placebo Powder
Arm Type
Placebo Comparator
Arm Description
Patients will take 30 grams of placebo powder daily for up to 30 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry Powder
Other Intervention Name(s)
Blueberry powder from the U.S. Highbush Blueberry Council.
Intervention Description
Patients will take 30 grams of blueberry powder daily for up to 30 days
Intervention Type
Other
Intervention Name(s)
Placebo Powder
Intervention Description
Patients will take 30 grams of placebo powder daily for up to 30 days.
Primary Outcome Measure Information:
Title
Change from Baseline and Placebo in Uric Acid Level in Patients Randomized to Treatment Group
Description
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.
Time Frame
Baseline, ~30 days later
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Percent change and absolute change of blood pressure from baseline and placebo
Time Frame
Baseline, ~30 days, ~45 days, ~75 days
Title
Body Weight
Description
Percent change and absolute change of body weight from baseline and placebo
Time Frame
Baseline, ~30 days, ~45 days, ~75 days
Title
Quality of Life
Description
Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time Frame
Baseline, ~30 days, ~45 days, ~75 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Riche, Pharm.D.
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marion Wofford, M.D., M.P.H.
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Blueberries on Uric Acid and Quality of Life
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