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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497077
• Other study ID #: 801765
• Status: Completed
• Phase: N/A
• Start date: September 15, 2015
• Est. completion date: May 30, 2017

Study information

• Verified date: July 2020
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 30, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• tart cherry
Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
• placebo
either cornstarch capsule or kool-aid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	Marywood University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in uric acid	uric acid (mg/dL) measured via assay	1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
Primary	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