- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02922920
Effects of Tart Cherry Juice on the Body
October 3, 2016 updated by: Sheau Ching Chai, University of Delaware
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Thirty-seven older adults were randomly assigned to drink 16 oz per day of either tart cherry juice or placebo drink for 12 weeks.
Blood and urine samples were collected at baseline and 12 weeks to assess biomarkers.
Physical activity and 3-day diet records were also collected throughout the study.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19716
- University of Delaware
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Age 65-80
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tart cherry juice
Participants consumed 16 fl.
oz of tart cherry juice daily for 12 weeks.
|
16 fl. oz of tart cherry juice
|
Placebo Comparator: Placebo juice
Participants consumed 16 fl.
oz of placebo daily for 12 weeks.
|
16 fl. oz of placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: Baseline and 12 weeks
|
Change from baseline in cognitive test performance at 12 weeks
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular risk factors
Time Frame: Baseline and 12 weeks
|
Fasting blood samples were collected at baseline and 12 weeks.
Change from baseline in cardiovascular risk factors including blood lipid profiles, atherogenic risk ratios, blood glucose, hemoglobin A1c, insulin, and blood pressure at 12 weeks.
|
Baseline and 12 weeks
|
Oxidative stress markers
Time Frame: Baseline and 12 weeks
|
Fasting blood samples were collected at baseline and 12 weeks.
Change from baseline in plasma 8-oxoguanine (ng/ml), plasma 8-hydroxy-2deoxy-guanosine (ng/mL), plasma hydroxynonenal (ng/ml), and plasma malondialdehyde (pmole/L) at 12 weeks.
|
Baseline and 12 weeks
|
Inflammatory markers
Time Frame: Baseline and 12 weeks
|
Fasting blood samples were collected at baseline and 12 weeks.
Change from baseline in plasma tumor-necrosis factor-α (pg/mL) and plasma high-sensitivity C-reactive protein (ng/mL) at 12 weeks.
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sheau Ching Chai, PhD, RD, University of Delaware
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
September 20, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Estimate)
October 4, 2016
Last Update Submitted That Met QC Criteria
October 3, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15A00149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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