Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity

NCT ID: NCT04497077

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-15

Study Completion Date

2017-05-30

Brief Summary

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A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice daily) on inflammation and oxidative capacity.

Detailed Description

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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

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Inflammation Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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single dose tart cherry capsule

single dose tart cherry capsule

Group Type EXPERIMENTAL

tart cherry

Intervention Type DIETARY_SUPPLEMENT

Either tart cherry juice or freeze dried powdered tart cherry in capsule was given

double dose tart cherry capsule

double dose tart cherry capsule

Group Type EXPERIMENTAL

tart cherry

Intervention Type DIETARY_SUPPLEMENT

Either tart cherry juice or freeze dried powdered tart cherry in capsule was given

single dose tart cherry juice

single dose tart cherry juice

Group Type EXPERIMENTAL

tart cherry

Intervention Type DIETARY_SUPPLEMENT

Either tart cherry juice or freeze dried powdered tart cherry in capsule was given

double dose tart cherry juice

double dose tart cherry juice

Group Type EXPERIMENTAL

tart cherry

Intervention Type DIETARY_SUPPLEMENT

Either tart cherry juice or freeze dried powdered tart cherry in capsule was given

single placebo capsule

single placebo capsule

Group Type EXPERIMENTAL

placebo

Intervention Type DIETARY_SUPPLEMENT

either cornstarch capsule or kool-aid

single placebo juice

single placebo juice

Group Type EXPERIMENTAL

placebo

Intervention Type DIETARY_SUPPLEMENT

either cornstarch capsule or kool-aid

Interventions

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tart cherry

Either tart cherry juice or freeze dried powdered tart cherry in capsule was given

Intervention Type DIETARY_SUPPLEMENT

placebo

either cornstarch capsule or kool-aid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marywood University

OTHER

Sponsor Role collaborator

Ohio University

OTHER

Sponsor Role lead

Responsible Party

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Angela Hillman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 33506357 (View on PubMed)

Other Identifiers

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801765

Identifier Type: -

Identifier Source: org_study_id

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