Clinical trial NCT04837274: Anderson Study 1 - Tart Cherry Study
Official title: Effects Of Tary Cherry Ingestion On Food-Induced Serum Uric Acid Elevation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Services Research
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Anderson Global Group, LLC
First posted: 2021-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Uric Acid Changes
timeFrame: Measured at baseline (prior to supplementation (Pre)), and after 60, 120, 180 and 240 minutes
Secondary outcomes:
measure: Side Effects Assessment
timeFrame: Measured at baseline prior to supplementation (Pre)
measure: Side Effects Assessment
timeFrame: Measured after 240 minutes (Post)
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Lab - Human Clinical Research Facility
state: Texas
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References: