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

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

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:
  • Blueberry powder from the U.S. Highbush Blueberry Council.
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.

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.

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