NCT02922920

Brief Summary

Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about the effects of drinking tart cherry juice on cardiovascular and cognitive health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

September 20, 2016

Last Update Submit

October 3, 2016

Conditions

Cardiovascular Risk FactorsAge-Related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Change from baseline in cognitive test performance at 12 weeks

    Baseline and 12 weeks

Secondary Outcomes (3)

  • Cardiovascular risk factors

    Baseline and 12 weeks

  • Oxidative stress markers

    Baseline and 12 weeks

  • Inflammatory markers

    Baseline and 12 weeks

Study Arms (2)

Tart cherry juice

EXPERIMENTAL

Participants consumed 16 fl. oz of tart cherry juice daily for 12 weeks.

Other: Tart cherry juice

Placebo juice

PLACEBO COMPARATOR

Participants consumed 16 fl. oz of placebo daily for 12 weeks.

Other: Placebo

Interventions

Tart cherry juiceOTHER

16 fl. oz of tart cherry juice

Tart cherry juice
PlaceboOTHER

16 fl. oz of placebo

Placebo juice

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65-80

You may not qualify if:

  • Allergic to tart cherries
  • Heavy smoker
  • Taking medications that affect cognitive function
  • History of neurological disorders
  • History of traumatic brain injury
  • History of stroke
  • Clinical diagnosis of diabetes
  • Clinical diagnosis of Alzheimer's Disease/Dementia
  • GI disease
  • Kidney disease
  • Liver disease
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Study Officials

  • Sheau Ching Chai, PhD, RD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 20, 2016

First Posted

October 4, 2016

Study Start

November 1, 2014

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)