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Impact of Blueberries on Uric Acid and Quality of Life

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ClinicalTrials.gov Identifier: NCT01532622
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : October 22, 2013
Sponsor:
Collaborator:
U.S. Highbush Blueberry Council
Information provided by (Responsible Party):
Daniel Riche, University of Mississippi Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2012
First Posted Date  ICMJE February 14, 2012
Last Update Posted Date October 22, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
  • Change from Baseline in Uric Acid Level in Patients Randomized to Treatment Group [ Time Frame: baseline, 4 weeks later ]
    Percent change in uric acid level from baseline after 4 weeks 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 a 2-week washout period post taking placebo.
  • Change from Baseline in Uric Acid Level in Patients Randomized to Placebo Group [ Time Frame: baseline, 4 weeks later ]
    Percent change in uric acid level from baseline after 4 weeks of treatment with placebo. Since this is designed as a crossover trial, baseline could represent uric acid level at the beginning of the study or after a 2-week washout period post taking blueberry powder.
Change History Complete list of historical versions of study NCT01532622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2013)
  • Blood Pressure [ Time Frame: Baseline, ~30 days, ~45 days, ~75 days ]
    Percent change and absolute change of blood pressure from baseline and placebo
  • Body Weight [ Time Frame: Baseline, ~30 days, ~45 days, ~75 days ]
    Percent change and absolute change of body weight from baseline and placebo
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
  • Blood Pressure [ Time Frame: baseline, 4 weeks, 6 weeks, 10 weeks ]
    Percent change and absolute change of blood pressure from baseline.
  • Body Weight [ Time Frame: baseline, 4 weeks, 6 weeks, 10 weeks ]
    Percent change and absolute change of body weight from baseline.
  • Quality of Life [ Time Frame: baseline, 4 weeks, 6 weeks, 10 weeks ]
    Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Blueberries on Uric Acid and Quality of Life
Official Title  ICMJE Impact of Blueberries on Uric Acid and Quality of Life
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperuricemia
Intervention  ICMJE
  • 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.
  • Other: Placebo Powder
    Patients will take 30 grams of placebo powder daily for up to 30 days.
Study Arms  ICMJE
  • Active Comparator: Blueberry Powder
    Patients will take 30 grams of blueberry powder daily for up to 30 days.
    Intervention: Dietary Supplement: Blueberry Powder
  • Placebo Comparator: Placebo Powder
    Patients will take 30 grams of placebo powder daily for up to 30 days.
    Intervention: Other: Placebo Powder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01532622
Other Study ID Numbers  ICMJE 2011-0218
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Riche, University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE U.S. Highbush Blueberry Council
Investigators  ICMJE
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
PRS Account University of Mississippi Medical Center
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP