Health Services Research
Conditions
Brief summary
The purpose of this study is to examine if tart cherry reduces food-induced elevations in serum uric acid.
Detailed description
Gout is a painful form of arthritis that is caused by hyperuricemia (high uric acid levels) that form crystals in the joints. Ingestion of food and/or beverages containing high purine levels (e.g., beef, game meats, liver, shellfish, herring, mackerel, anchovies, sardines, mushrooms, dried beans and peas, sweetbreads, excessive alcohol, etc.) increase uric acid levels and thereby can complicate the management of uric acid levels in individuals with hyeruricemia and/or gout. Prior research has shown that ingestion of a chrysanthemum flower oil containing a high level of polyphenols significantly reduced the uricemic response to ingesting a meal high in purines. Additionally, black cherry and grape juice extracts are purported to have uric acid lowering properties. We have previoulsy reported that tart cherry powder, another naturally occuriring source of phlyphenols, lessens exercise-induced inflammation. This study will examine if tart cherry can also reduce the uricemic response to ingesting a high purine containing meal. If so, this may provide another dietary approach to help individuals manage their uric acid levels.
Interventions
DIETARY_SUPPLEMENTPlacebo
Dextrose (480 mg)
DIETARY_SUPPLEMENTActive
Tary Cherry (480 mg)
Sponsors
Anderson Global Group, LLC
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* They are healthy males or females ages 30 to 60 years with fasting serum uric acid (UA) levels between 5.5 and 8.0 mg/dl obtained during the familiarization/screening visit; * They have a willingness to provide voluntary, written, informed consent to participate in the study;
Exclusion criteria
* They take prescription (Rx) medications (i.e., Uloric, Krystexxa, etc.) or dietary supplements known to have UA-reducing activity (i.e., black cherry, devil's claw, grape seed extracts, etc.); * They have regular diseases requiring regular prescription (Rx) medications (birth control is allowed); * They have abnormal/out of range values in laboratory tests determined at the familiarization/screening visit; * They have an allergy to tart cherry or immunoglobulin E; * They are pregnant, trying to become pregnant or breastfeeding;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uric Acid Changes | Measured at baseline (prior to supplementation (Pre)), and after 60, 120, 180 and 240 minutes | Serum Uric Acid changes to ingesting a high purine containing meal, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects Assessment | Measured at baseline prior to supplementation (Pre) | Abdominal Side Effects Assessment on a 5 point likert scale |
Countries
United States
Outcome results
None listed