Clinical trial NCT04497077: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Oxidative Stress
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: Marywood University
First posted: 2020-08-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: Change in c-reactive protein
timeFrame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
measure: Change in uric acid
timeFrame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
measure: Change in oxidative capacity
timeFrame: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.