InflammationNCT04497077
Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity
A study testing tart cherry in people with Inflammation and Oxidative Stress, run by Ohio University.
Trial summary
A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice daily) on inflammation and oxidative capacity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Oxidative Stress
- What is being tested?
- tart cherry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2015to 30 May 2017
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- free of cardiovascular, metabolic and inflammatory conditions
- non-smokers
- no known allergy to cherries or cherry juice
- not be taking food supplements (turmeric/curcumin, cherry products, greens, etc.).
Who cannot join
- quit smoking less than one year ago.
- currently being treated for arthritis or an inflammatory condition.
- currently being treated for uncontrolled cardiovascular disease, high blood pressure, diabetes, fibromyalgia, or irritable bowel syndrome.
- pregnant.
- regularly consume cherries or are allergic to cherries or dairy.
- currently use anti-inflammatory medications,
- have used corticosteroids in the last two months.
About this study
A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice daily) on inflammation and oxidative capacity.
Read the detailed description
Participants will be randomly allocated to a group: one tart cherry capsule daily, two tart cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo. Participants will arrive to the lab at 8 am after an overnight fast of 10 hours. They will provide a blood sample and then ingest their study treatment. Participants will stay in the lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for another blood draw. At this time if they are in a twice daily group they will receive their second treatment for the day. All participants will come back to the lab 24 hours later where they will give a blood sample and receive their next treatment. If they are in the twice daily group they will be provided with their next dose and given instructions to consume it in 8 hours. Participants will arrive 24 hours later for a final blood draw with no supplementation.
Blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours post-ingestion. Samples will be analyzed for plasma oxygen radical absorbance capacity (ORAC), uric acid (UA), and C-reactive protein (CRP).
- Conditions
- Inflammation, Oxidative Stress
- Being tested
- tart cherry, placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tart cherryDietary supplement
Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
placeboDietary supplement
either cornstarch capsule or kool-aid
| Study group | Role | What they receive |
|---|---|---|
| single dose tart cherry capsule | Experimental | single dose tart cherry capsule Receives: Dietary Supplement: tart cherry |
| double dose tart cherry capsule | Experimental | double dose tart cherry capsule Receives: Dietary Supplement: tart cherry |
| single dose tart cherry juice | Experimental | single dose tart cherry juice Receives: Dietary Supplement: tart cherry |
| double dose tart cherry juice | Experimental | double dose tart cherry juice Receives: Dietary Supplement: tart cherry |
| single placebo capsule | Experimental | single placebo capsule Receives: Dietary Supplement: placebo |
| single placebo juice | Experimental | single placebo juice Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in c-reactive protein
c-reactive protein (mg/L) measured via assay
Measured: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
Change in uric acid
uric acid (mg/dL) measured via assay
Measured: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
Change in oxidative capacity
oxygen radical absorbance capacity (uM Trolox equivalents) measured via assay
Measured: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start15 Sep 2015
- Primary completion30 Dec 2016
- Study completion30 May 2017
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 InflammationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Marywood University
- Responsible party
- Principal investigator, Angela Hillman, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497077
- Sponsor's protocol ID
- 801765
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request
Publications
Hillman AR, Uhranowsky K. Acute Ingestion of Montmorency Tart Cherry Reduces Serum Uric Acid but Has no Impact on High Sensitivity C-Reactive Protein or Oxidative Capacity. Plant Foods Hum Nutr. 2021 Mar;76(1):83-89. doi: 10.1007/s11130-021-00879-7. Epub 2021 Jan 27.
PubMed 33506357
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity
- ClinicalTrials.gov ID
- NCT04497077
- Acronym / sponsor ID
- 801765
- Conditions
- Inflammation, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Marywood University
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 4 Aug 2020 (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.
A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice daily) on inflammation and oxidative capacity.
Detailed description
Participants will be randomly allocated to a group: one tart cherry capsule daily, two tart cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo. Participants will arrive to the lab at 8 am after an overnight fast of 10 hours. They will provide a blood sample and then ingest their study treatment. Participants will stay in the lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for another blood draw. At this time if they are in a twice daily group they will receive their second treatment for the day. All participants will come back to the lab 24 hours later where they will give a blood sample and receive their next treatment. If they are in the twice daily group they will be provided with their next dose and given instructions to consume it in 8 hours. Participants will arrive 24 hours later for a final blood draw with no supplementation.
Blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours post-ingestion. Samples will be analyzed for plasma oxygen radical absorbance capacity (ORAC), uric acid (UA), and C-reactive protein (CRP).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| single dose tart cherry capsule | Experimental | Dietary Supplement: tart cherrysingle dose tart cherry capsule |
| double dose tart cherry capsule | Experimental | Dietary Supplement: tart cherrydouble dose tart cherry capsule |
| single dose tart cherry juice | Experimental | Dietary Supplement: tart cherrysingle dose tart cherry juice |
| double dose tart cherry juice | Experimental | Dietary Supplement: tart cherrydouble dose tart cherry juice |
| single placebo capsule | Experimental | Dietary Supplement: placebosingle placebo capsule |
| single placebo juice | Experimental | Dietary Supplement: placebosingle placebo juice |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- free of cardiovascular, metabolic and inflammatory conditions
- non-smokers
- no known allergy to cherries or cherry juice
- not be taking food supplements (turmeric/curcumin, cherry products, greens, etc.).
Key exclusion criteria (7 listed)
- quit smoking less than one year ago.
- currently being treated for arthritis or an inflammatory condition.
- currently being treated for uncontrolled cardiovascular disease, high blood pressure, diabetes, fibromyalgia, or irritable bowel syndrome.
- pregnant.
- regularly consume cherries or are allergic to cherries or dairy.
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 |
|---|---|---|
| tart cherryEither tart cherry juice or freeze dried powdered tart cherry in capsule was given | Dietary supplement | double dose tart cherry capsule, double dose tart cherry juice, single dose tart cherry capsule, single dose tart cherry juice |
| placeboeither cornstarch capsule or kool-aid | Dietary supplement | single placebo capsule, single placebo juice |
Primary outcome
Change in c-reactive protein
Time frame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
c-reactive protein (mg/L) measured via assay
Change in uric acid
Time frame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
uric acid (mg/dL) measured via assay
Change in oxidative capacity
Time frame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
oxygen radical absorbance capacity (uM Trolox equivalents) measured via assay
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 4 Aug 2020.
- Derived from this study: PubMed 33506357Hillman AR, Uhranowsky K. Acute Ingestion of Montmorency Tart Cherry Reduces Serum Uric Acid but Has no Impact on High Sensitivity C-Reactive Protein or Oxidative Capacity. Plant Foods Hum Nutr. 2021 Mar;76(1):83-89. doi: 10.1007/s11130-021-00879-7. Epub 2021 Jan 27.
- Individual participant dataSharing planned: No. upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tart cherry in people with Inflammation and Oxidative Stress, run by Ohio University.
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 4 inclusion and 7 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in c-reactive protein (time frame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion). The study lists 3 primary outcomes in all. 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 NCT04497077, 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 4 Aug 2020.