Health Services ResearchAS1NCT04837274
Anderson Study 1 - Tart Cherry Study
A study testing Active in people with Health Services Research, run by Texas A&M University at 1 site in United States.
Trial summary
The purpose of this study is to examine if tart cherry reduces food-induced elevations in serum uric acid. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Services Research
- What is being tested?
- Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Lab - Human Clinical Research Facility
College Station, Texas, 77845
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Services Research
- Being tested
- Placebo, Active
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Dextrose (480 mg)
ActiveDietary supplement
Tary Cherry (480 mg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dextrose (480 mg) Receives: Dietary Supplement: Placebo |
| Active | Experimental | Tart Cherry (480 mg) Receives: Dietary Supplement: Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uric Acid Changes
Serum Uric Acid changes to ingesting a high purine containing meal,
Measured: Measured at baseline (prior to supplementation (Pre)), and after 60, 120, 180 and 240 minutes
Secondary outcomes (2)
Side Effects Assessment
Abdominal Side Effects Assessment on a 5 point likert scale
Measured: Measured at baseline prior to supplementation (Pre)
Side Effects Assessment
Abdominal Side Effects Assessment on a 5 point likert scale
Measured: Measured after 240 minutes (Post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start10 Apr 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Services ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Anderson Global
- Responsible party
- Principal investigator, Richard B. Kreider, Texas A&M University
- Investigators
- Richard B Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837274
- Sponsor's protocol ID
- IRB2020-0164F
- Acronym
- AS1
- Status last verified
- Oct 2022
- First submitted
- 31 Mar 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39408358
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Tary Cherry Ingestion On Food-Induced Serum Uric Acid Elevation
- ClinicalTrials.gov ID
- NCT04837274
- Acronym / sponsor ID
- AS1 / IRB2020-0164F
- Conditions
- Health Services Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Anderson Global
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine if tart cherry reduces food-induced elevations in serum uric acid.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDextrose (480 mg) |
| Active | Experimental | Dietary Supplement: ActiveTart Cherry (480 mg) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDextrose (480 mg) | Dietary supplement | Placebo |
| ActiveTary Cherry (480 mg) | Dietary supplement | Active |
Primary outcome
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,
2 secondary outcomes
Side Effects Assessment
Time frame: Measured at baseline prior to supplementation (Pre)
Side Effects Assessment
Time frame: Measured after 240 minutes (Post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 39408358Gonzalez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Kreider, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Health Services Research, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uric Acid Changes (time frame: Measured at baseline (prior to supplementation (Pre)), and after 60, 120, 180 and 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.