Effects of Tart Cherry Juice on the Body

Cardiovascular Risk Factors Clinical Trial

Official title:

Effects of Tart Cherry Juice on the Body

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922920
• Other study ID #: 15A00149
• 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

Related Conditions & MeSH terms

• Age-Related Cognitive Decline
• Cardiovascular Risk Factors

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