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Anderson Study 1 - Tart Cherry Study (AS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04837274
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
Anderson Global Group, LLC
Information provided by (Responsible Party):
Richard B. Kreider, Texas A&M University

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

Condition or disease Intervention/treatment Phase
Health Services Research Dietary Supplement: Placebo Dietary Supplement: Active Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects Of Tary Cherry Ingestion On Food-Induced Serum Uric Acid Elevation
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Dextrose (480 mg)
 Dietary Supplement: Placebo
Dextrose (480 mg)
Experimental: Active
Tart Cherry (480 mg)
 Dietary Supplement: Active
Tary Cherry (480 mg)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837274


Contacts
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Contact: Richard B Kreider, PhD 9794581498 rbkreider@tamu.edu

Locations
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United States, Texas
Exercise & Sport Nutrition Lab - Human Clinical Research Facility Recruiting
College Station, Texas, United States, 77845
Contact: Richard B Kreider, PhD    979-458-1498    rbkreider@tamu.edu   
Contact: Chris Rasmussen, MS    9794581741    crasmussen@tamu.edy   
Sponsors and Collaborators
Texas A&M University
Anderson Global Group, LLC
Investigators
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Principal Investigator: Richard B Kreider, PhD Texas A&M University
More Information
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Responsible Party: Richard B. Kreider, Executive Director, Human Clinical Research Facility, Texas A&M University
ClinicalTrials.gov Identifier: NCT04837274    
Other Study ID Numbers: IRB2008-0164F
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No