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OpenTrials
Completed

NCT Number: NCT04497077

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

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

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Key information

Conditions

Inflammation Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tart Cherry

Dietary Supplement

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

Placebo

Dietary Supplement

either cornstarch capsule or kool-aid

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • Marywood University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 4, 2020
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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