Impact of Blueberries on Uric Acid and Quality of Life

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Blueberries on Uric Acid and Quality of Life

Conditions
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Hyperuricemia

Intervention / Treatment
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* Dietary Supplement: Blueberry Powder
* Other: Placebo Powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blueberry Powder<br>Patients will take 30 grams of blueberry powder daily for up to 30 days. | Dietary Supplement: Blueberry Powder<br>* Patients will take 30 grams of blueberry powder daily for up to 30 days<br>* Other names: Blueberry powder from the U.S. Highbush Blueberry Council.;|
| Placebo Comparator: Placebo Powder<br>Patients will take 30 grams of placebo powder daily for up to 30 days. | Other: Placebo Powder<br>* Patients will take 30 grams of placebo powder daily for up to 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Percent change and absolute change of blood pressure from baseline and placebo | Baseline,  30 days,  45 days,  75 days | 
| Body Weight | Percent change and absolute change of body weight from baseline and placebo | Baseline,  30 days,  45 days,  75 days | 
| Quality of Life | Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) | Baseline,  30 days,  45 days,  75 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blueberry