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Completed

NCT Number: NCT04837274

Anderson Study 1 - Tart Cherry Study

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

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, 77845, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Placebo

Dietary Supplement

Dextrose (480 mg)

Active

Dietary Supplement

Tary Cherry (480 mg)

Primary outcomes

  1. Uric Acid Changes

    Time frame: 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 outcomes

  1. Side Effects Assessment

    Time frame: Measured at baseline prior to supplementation (Pre)

    Abdominal Side Effects Assessment on a 5 point likert scale

  2. Side Effects Assessment

    Time frame: Measured after 240 minutes (Post)

    Abdominal Side Effects Assessment on a 5 point likert scale

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Anderson Global

Registry information

Official study title

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

Acronym: AS1

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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