Anderson Study 1 - Tart Cherry Study

NCT ID: NCT04837274

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2021-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Health Services Research

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double (Participant, Investigator)

Study Groups

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Placebo

Dextrose (480 mg)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dextrose (480 mg)

Active

Tart Cherry (480 mg)

Group Type EXPERIMENTAL

Active

Intervention Type DIETARY_SUPPLEMENT

Tary Cherry (480 mg)

Interventions

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Placebo

Dextrose (480 mg)

Intervention Type DIETARY_SUPPLEMENT

Active

Tary Cherry (480 mg)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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;
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anderson Global Group, LLC

UNKNOWN

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Richard B. Kreider

Executive Director, Human Clinical Research Facility

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard B Kreider, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

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Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, United States

Site Status

Countries

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United States

References

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Gonzalez DE, Kendra JA, Dickerson BL, Yoo C, Ko J, McAngus K, Martinez V, Leonard M, Johnson SE, Xing D, Sowinski RJ, Rasmussen CJ, Kreider RB. Effects of Acute and One-Week Supplementation with Montmorency Tart Cherry Powder on Food-Induced Uremic Response and Markers of Health: A Proof-of-Concept Study. Nutrients. 2024 Oct 6;16(19):3391. doi: 10.3390/nu16193391.

Reference Type DERIVED
PMID: 39408358 (View on PubMed)

Other Identifiers

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IRB2020-0164F

Identifier Type: -

Identifier Source: org_study_id

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