Anderson Study 1 - Tart Cherry Study (AS1)

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

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

Study Overview

• Status: Completed
• Conditions: Health Services Research
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Active

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77845
      • Exercise & Sport Nutrition Lab - Human Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects Assessment	Abdominal Side Effects Assessment on a 5 point likert scale	Measured at baseline prior to supplementation (Pre)
Side Effects Assessment	Abdominal Side Effects Assessment on a 5 point likert scale	Measured after 240 minutes (Post)

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: Anderson Global Group, LLC
• Investigators: Principal Investigator: Richard B Kreider, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB2020-0164F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No