Impact of Blueberries on Uric Acid and Quality of Life

Hyperuricemia Clinical Trial

Official title:

Impact of Blueberries on Uric Acid and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532622
• Other study ID #: 2011-0218
• Status: Completed
• Phase: N/A
• First received: January 30, 2012
• Last updated: October 18, 2013
• Start date: January 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Dietary Supplement:
• Blueberry Powder
Patients will take 30 grams of blueberry powder daily for up to 30 days

Other:
• Placebo Powder
Patients will take 30 grams of placebo powder daily for up to 30 days.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	U.S. Highbush Blueberry Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood Pressure	Percent change and absolute change of blood pressure from baseline and placebo	Baseline, ~30 days, ~45 days, ~75 days	No
Secondary	Body Weight	Percent change and absolute change of body weight from baseline and placebo	Baseline, ~30 days, ~45 days, ~75 days	No
Secondary	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	No