Impact of Blueberries on Uric Acid and Quality of Life

This study has been completed.
Sponsor:
Collaborator:
U.S. Highbush Blueberry Council
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01532622
First received: January 30, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Hyperuricemia
Dietary Supplement: Blueberry Powder
Other: Placebo Powder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Blueberries on Uric Acid and Quality of Life

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Change from Baseline and Placebo in Uric Acid Level in Patients Randomized to Treatment Group [ Time Frame: Baseline, ~30 days later ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, ~30 days, ~45 days, ~75 days ] [ Designated as safety issue: No ]
    Percent change and absolute change of blood pressure from baseline and placebo

  • Body Weight [ Time Frame: Baseline, ~30 days, ~45 days, ~75 days ] [ Designated as safety issue: No ]
    Percent change and absolute change of body weight from baseline and placebo

  • Quality of Life [ Time Frame: Baseline, ~30 days, ~45 days, ~75 days ] [ Designated as safety issue: No ]
    Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI)


Enrollment: 30
Study Start Date: January 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Blueberry Powder
Patients will take 30 grams of blueberry powder daily for up to 30 days.
Dietary Supplement: Blueberry Powder
Patients will take 30 grams of blueberry powder daily for up to 30 days
Other Name: 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.
Other: Placebo Powder
Patients will take 30 grams of placebo powder daily for up to 30 days.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532622

Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
U.S. Highbush Blueberry Council
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
  More Information

No publications provided

Responsible Party: Daniel Riche, Associate Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01532622     History of Changes
Other Study ID Numbers: 2011-0218
Study First Received: January 30, 2012
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Blueberry

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014