Anderson Study 1 - Tart Cherry Study

Not Applicable

Completed

• Conditions: Health Services Research
• Interventions: Dietary Supplement: Active; Dietary Supplement: Placebo

• Registration Number: NCT04837274
• Lead Sponsor: Texas A&M University

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.

Study Timeline

• Study Start: 2020-04-10
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2022-10
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	Active	Tart Cherry (480 mg)
Placebo	Placebo	Dextrose (480 mg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Side Effects Assessment	Measured after 240 minutes (Post)	Abdominal Side Effects Assessment on a 5 point likert scale

Trial Locations

Locations (1)

Exercise & Sport Nutrition Lab - Human Clinical Research Facility; 🇺🇸 College Station, Texas, United States