Anderson Study 1 - Tart Cherry Study

Study Overview
=================
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.

Official Title
-----------------
Effects Of Tary Cherry Ingestion On Food-Induced Serum Uric Acid Elevation

Conditions
-----------------
Health Services Research

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Active


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Dextrose (480 mg) | Dietary Supplement: Placebo<br>* Dextrose (480 mg)<br>|
| Experimental: Active<br>Tart Cherry (480 mg) | Dietary Supplement: Active<br>* Tary Cherry (480 mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uric Acid Changes | Serum Uric Acid changes to ingesting a high purine containing meal, | Measured at baseline (prior to supplementation (Pre)), and after 60, 120, 180 and 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects Assessment | Abdominal Side Effects Assessment on a 5 point likert scale | Measured at baseline prior to supplementation (Pre) | 
| Side Effects Assessment | Abdominal Side Effects Assessment on a 5 point likert scale | Measured after 240 minutes (Post) |