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Effects of Tart Cherry Juice on the Body

Primary Purpose

Cardiovascular Risk Factors, Age-Related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tart cherry juice
Placebo
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factors

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tart cherry juice

Placebo juice

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cognitive function
Change from baseline in cognitive test performance at 12 weeks

Secondary Outcome Measures

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.
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.
Inflammatory markers
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.

Full Information

First Posted
September 20, 2016
Last Updated
October 3, 2016
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT02922920
Brief Title
Effects of Tart Cherry Juice on the Body
Official Title
Effects of Tart Cherry Juice on the Body
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors, Age-Related Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tart cherry juice
Arm Type
Experimental
Arm Description
Participants consumed 16 fl. oz of tart cherry juice daily for 12 weeks.
Arm Title
Placebo juice
Arm Type
Placebo Comparator
Arm Description
Participants consumed 16 fl. oz of placebo daily for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Tart cherry juice
Intervention Description
16 fl. oz of tart cherry juice
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
16 fl. oz of placebo
Primary Outcome Measure Information:
Title
Cognitive function
Description
Change from baseline in cognitive test performance at 12 weeks
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Cardiovascular risk factors
Description
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.
Time Frame
Baseline and 12 weeks
Title
Oxidative stress markers
Description
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.
Time Frame
Baseline and 12 weeks
Title
Inflammatory markers
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheau Ching Chai, PhD, RD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Tart Cherry Juice on the Body

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