NCT04497077

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

July 27, 2020

Last Update Submit

July 29, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (6)

single dose tart cherry capsule

EXPERIMENTAL

single dose tart cherry capsule

Dietary Supplement: tart cherry

double dose tart cherry capsule

EXPERIMENTAL

double dose tart cherry capsule

Dietary Supplement: tart cherry

single dose tart cherry juice

EXPERIMENTAL

single dose tart cherry juice

Dietary Supplement: tart cherry

double dose tart cherry juice

EXPERIMENTAL

double dose tart cherry juice

Dietary Supplement: tart cherry

single placebo capsule

EXPERIMENTAL

single placebo capsule

Dietary Supplement: placebo

single placebo juice

EXPERIMENTAL

single placebo juice

Dietary Supplement: placebo

Interventions

tart cherryDIETARY_SUPPLEMENT

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

double dose tart cherry capsuledouble dose tart cherry juicesingle dose tart cherry capsulesingle dose tart cherry juice
placeboDIETARY_SUPPLEMENT

either cornstarch capsule or kool-aid

single placebo capsulesingle placebo juice

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 4, 2020

Study Start

September 15, 2015

Primary Completion

December 30, 2016

Study Completion

May 30, 2017

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

upon request