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

Primary Purpose

Inflammation, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tart cherry
placebo
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    single dose tart cherry capsule

    double dose tart cherry capsule

    single dose tart cherry juice

    double dose tart cherry juice

    single placebo capsule

    single placebo juice

    Arm Description

    single dose tart cherry capsule

    double dose tart cherry capsule

    single dose tart cherry juice

    double dose tart cherry juice

    single placebo capsule

    single placebo juice

    Outcomes

    Primary Outcome Measures

    Change in c-reactive protein
    c-reactive protein (mg/L) measured via assay
    Change in uric acid
    uric acid (mg/dL) measured via assay
    Change in oxidative capacity
    oxygen radical absorbance capacity (uM Trolox equivalents) measured via assay

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2020
    Last Updated
    July 29, 2020
    Sponsor
    Ohio University
    Collaborators
    Marywood University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04497077
    Brief Title
    Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity
    Official Title
    Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2015 (Actual)
    Primary Completion Date
    December 30, 2016 (Actual)
    Study Completion Date
    May 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio University
    Collaborators
    Marywood University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation, Oxidative Stress

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    single dose tart cherry capsule
    Arm Type
    Experimental
    Arm Description
    single dose tart cherry capsule
    Arm Title
    double dose tart cherry capsule
    Arm Type
    Experimental
    Arm Description
    double dose tart cherry capsule
    Arm Title
    single dose tart cherry juice
    Arm Type
    Experimental
    Arm Description
    single dose tart cherry juice
    Arm Title
    double dose tart cherry juice
    Arm Type
    Experimental
    Arm Description
    double dose tart cherry juice
    Arm Title
    single placebo capsule
    Arm Type
    Experimental
    Arm Description
    single placebo capsule
    Arm Title
    single placebo juice
    Arm Type
    Experimental
    Arm Description
    single placebo juice
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    tart cherry
    Intervention Description
    Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    either cornstarch capsule or kool-aid
    Primary Outcome Measure Information:
    Title
    Change in c-reactive protein
    Description
    c-reactive protein (mg/L) measured via assay
    Time Frame
    1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
    Title
    Change in uric acid
    Description
    uric acid (mg/dL) measured via assay
    Time Frame
    1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
    Title
    Change in oxidative capacity
    Description
    oxygen radical absorbance capacity (uM Trolox equivalents) measured via assay
    Time Frame
    1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    upon request
    Citations:
    PubMed Identifier
    33506357
    Citation
    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.
    Results Reference
    derived

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

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