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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress
• Intervention / Treatment: Dietary supplement: tart cherry; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single dose tart cherry capsule	Dietary supplement: tart cherry; Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
Experimental: double dose tart cherry capsule	Dietary supplement: tart cherry; Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
Experimental: single dose tart cherry juice	Dietary supplement: tart cherry; Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
Experimental: double dose tart cherry juice	Dietary supplement: tart cherry; Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
Experimental: single placebo capsule	Dietary supplement: placebo; either cornstarch capsule or kool-aid
Experimental: single placebo juice	Dietary supplement: placebo; either cornstarch capsule or kool-aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in c-reactive protein	c-reactive protein (mg/L) measured via assay	1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
Change in uric acid	uric acid (mg/dL) measured via assay	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	1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion

Collaborators and Investigators

• Sponsor: Ohio University
• Collaborators: Marywood University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 801765

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No