NCT04837274

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 27, 2024

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

March 31, 2021

Last Update Submit

June 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Side Effects Assessment

    Measured at baseline prior to supplementation (Pre)

  • Side Effects Assessment

    Measured after 240 minutes (Post)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dextrose (480 mg)

Dietary Supplement: Placebo

Active

EXPERIMENTAL

Tart Cherry (480 mg)

Dietary Supplement: Active

Interventions

PlaceboDIETARY_SUPPLEMENT

Dextrose (480 mg)

Placebo
ActiveDIETARY_SUPPLEMENT

Tary Cherry (480 mg)

Active

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise & Sport Nutrition Lab - Human Clinical Research Facility

College Station, Texas, 77845, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Richard B Kreider, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double (Participant, Investigator)
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Human Clinical Research Facility

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 8, 2021

Study Start

April 10, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

June 27, 2024

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations