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Anderson Study 1 - Tart Cherry Study (AS1)

Texas A&M University logo

Texas A&M University

Status

Completed

Conditions

Health Services Research

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Active

Study type

Interventional

Funder types

Other

Identifiers

NCT04837274
IRB2020-0164F

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Dextrose (480 mg)
Treatment:
Dietary Supplement: Placebo
Active
Experimental group
Description:
Tart Cherry (480 mg)
Treatment:
Dietary Supplement: Active

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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