HyperuricemiaNCT01532622
Impact of Blueberries on Uric Acid and Quality of Life
A study testing Blueberry Powder in people with Hyperuricemia, run by University of Mississippi Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Uric acid > 6.0 mg/dL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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.
- Conditions
- Hyperuricemia
- Being tested
- Blueberry Powder, Placebo Powder
- Keywords
- Blueberry
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry PowderDietary supplement
Also called Blueberry powder from the U.S. Highbush Blueberry Council.
Patients will take 30 grams of blueberry powder daily for up to 30 days
Placebo PowderOther
Patients will take 30 grams of placebo powder daily for up to 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Powder | Active comparator | Patients will take 30 grams of blueberry powder daily for up to 30 days. Receives: Dietary Supplement: Blueberry Powder |
| Placebo Powder | Placebo comparator | Patients will take 30 grams of placebo powder daily for up to 30 days. Receives: Other: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, ~30 days later
Secondary outcomes (3)
Blood Pressure
Percent change and absolute change of blood pressure from baseline and placebo
Measured: Baseline, ~30 days, ~45 days, ~75 days
Body Weight
Percent change and absolute change of body weight from baseline and placebo
Measured: Baseline, ~30 days, ~45 days, ~75 days
Quality of Life
Quality of life will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Measured: Baseline, ~30 days, ~45 days, ~75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Principal investigator, Daniel Riche, University of Mississippi Medical Center
- Investigators
- Daniel Riche, Pharm.D., Principal investigator, University of Mississippi Medical CenterMarion Wofford, M.D., M.P.H., Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532622
- Sponsor's protocol ID
- 2011-0218
- Status last verified
- Oct 2013
- First submitted
- 30 Jan 2012
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blueberries on Uric Acid and Quality of Life
- ClinicalTrials.gov ID
- NCT01532622
- Acronym / sponsor ID
- 2011-0218
- Conditions
- Hyperuricemia
- Keywords
- Blueberry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry Powder | Active comparator | Dietary Supplement: Blueberry PowderPatients will take 30 grams of blueberry powder daily for up to 30 days. |
| Placebo Powder | Placebo comparator | Other: Placebo PowderPatients will take 30 grams of placebo powder daily for up to 30 days. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Uric acid > 6.0 mg/dL
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry PowderAlso: Blueberry powder from the U.S. Highbush Blueberry Council.Patients will take 30 grams of blueberry powder daily for up to 30 days | Dietary supplement | Blueberry Powder |
| Placebo PowderPatients will take 30 grams of placebo powder daily for up to 30 days. | Other | Placebo Powder |
Primary outcome
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.
3 secondary outcomes
Blood Pressure
Time frame: Baseline, ~30 days, ~45 days, ~75 days
Body Weight
Time frame: Baseline, ~30 days, ~45 days, ~75 days
Quality of Life
Time frame: Baseline, ~30 days, ~45 days, ~75 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Riche, Pharm.D. principal investigator
University of Mississippi Medical Center
Marion Wofford, M.D., M.P.H. principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Powder in people with Hyperuricemia, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline and Placebo in Uric Acid Level in Patients Randomized to Treatment Group (time frame: Baseline, ~30 days later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.