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Completed

NCT Number: NCT01532622

Impact of Blueberries on Uric Acid and Quality of Life

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.

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Key information

Conditions

Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blueberry powder

Dietary Supplement

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 Powder

Other

Patients will take 30 grams of placebo powder daily for up to 30 days.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Blood Pressure

    Time frame: Baseline, ~30 days, ~45 days, ~75 days

    Percent change and absolute change of blood pressure from baseline and placebo

  2. Body Weight

    Time frame: Baseline, ~30 days, ~45 days, ~75 days

    Percent change and absolute change of body weight from baseline and placebo

  3. 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)

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • U.S. Highbush Blueberry Council

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 14, 2012
Registry last updated
Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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