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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02922920
Other study ID # 15A00149
Secondary ID
Status Completed
Phase N/A
First received September 20, 2016
Last updated October 3, 2016
Start date November 2014
Est. completion date September 2016

Study information

Verified date October 2016
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date September 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Other:
Tart cherry juice
16 fl. oz of tart cherry juice
Placebo
16 fl. oz of placebo

Locations

Country Name City State
United States University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive function Change from baseline in cognitive test performance at 12 weeks Baseline and 12 weeks No
Secondary Cardiovascular risk factors 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 No
Secondary Oxidative stress markers 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 No
Secondary Inflammatory markers Fasting blood samples were collected at baseline and 12 weeks. Change from baseline in plasma tumor-necrosis factor-a (pg/mL) and plasma high-sensitivity C-reactive protein (ng/mL) at 12 weeks. Baseline and 12 weeks No
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