Impact of Blueberries on Hyperuricemia and Gout

This study is currently recruiting participants.

Verified May 2013 by University of Mississippi Medical Center

Sponsor:

Information provided by (Responsible Party):

Daniel Riche, University of Mississippi Medical Center

ClinicalTrials.gov Identifier:

NCT01532622

First received: January 30, 2012

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

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 markers of cardiovascular health.

Condition	Intervention
Hyperuricemia Gout	Dietary Supplement: Blueberry Powder Dietary Supplement: 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 Hyperuricemia and Gout

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Vaccinium corymbosum

U.S. FDA Resources

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

Primary Outcome Measures:

Change from Baseline in Uric Acid Level in Patients Randomized to Treatment Group [ Time Frame: baseline, 4 weeks later ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Blood Pressure [ Time Frame: baseline, 4 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: No ]
Percent change and absolute change of blood pressure from baseline.
Body Weight [ Time Frame: baseline, 4 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: No ]
Percent change and absolute change of body weight from baseline.
Quality of Life [ Time Frame: baseline, 4 weeks, 6 weeks, 10 weeks ] [ Designated as safety issue: No ]
Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI).

Estimated Enrollment:	30
Study Start Date:	January 2012
Estimated Primary Completion Date:	July 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 four weeks.	Dietary Supplement: Blueberry Powder Patients will take 30 grams of blueberry powder daily for four weeks. 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 four weeks.	Dietary Supplement: Placebo Powder Patients will take 30 grams of placebo powder daily for 4 weeks.

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

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

Contacts

Contact: Daniel M Riche, Pharm.D.	(601)984-2640	driche@umc.edu
Contact: Hart W Berry, BSPharm	(662)322-2018	mwardlaw@umc.edu

Locations

United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216

Sponsors and Collaborators

University of Mississippi Medical Center

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, Assistant 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:	May 2, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:

Blueberry

Additional relevant MeSH terms:

Gout
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

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