Anderson Study 1 - Tart Cherry Study

Health Services Research Clinical Trial

— AS1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837274
• Other study ID #: IRB2008-0164F
• Status: Completed
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2022
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine if tart cherry reduces food-induced elevations in serum uric acid.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Health Services Research

Intervention

Dietary Supplement:
• Placebo
Dextrose (480 mg)
• Active
Tary Cherry (480 mg)

Locations

Country	Name	City	State
United States	Exercise & Sport Nutrition Lab - Human Clinical Research Facility	College Station	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Anderson Global Group, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side Effects Assessment	Abdominal Side Effects Assessment on a 5 point likert scale	Measured at baseline prior to supplementation (Pre)
Secondary	Side Effects Assessment	Abdominal Side Effects Assessment on a 5 point likert scale	Measured after 240 minutes (Post)