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Study on Whether Tart Cherry Juice Can Reduce Oxidative Stress and Inflammation

Primary Purpose

Oxidative Stress, Antioxidant Capacity, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tart Cherry Juice
Sponsored by
Kronos Longevity Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress focused on measuring oxidative stress, aging, ischemia-reperfusion

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • men and women, ages 55-80y, in good health, with >8 years of education
  • non-smoker
  • able to give informed consent

Exclusion Criteria:

  • use of anti-oxidant supplements, in excess of a standard multi-vitamins
  • current hormone replacement therapy
  • any history of significant chronic disease
  • uncontrolled hypertension
  • body mass index (BMI) > 30 kg/m2
  • high physical activity level, as determined by questions on the screening questionnaire
  • use of anti-inflammatory medication

Sites / Locations

  • Kronos Longevity Research Institute

Outcomes

Primary Outcome Measures

plasma F2-isoprostane response to a forearm ischemia-reperfusion challenge.

Secondary Outcome Measures

Urinary markers of oxidative damage.

Full Information

First Posted
February 17, 2009
Last Updated
February 18, 2009
Sponsor
Kronos Longevity Research Institute
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00847743
Brief Title
Study on Whether Tart Cherry Juice Can Reduce Oxidative Stress and Inflammation
Official Title
Effects of Tart Cherry Juice on Oxidative Stress and Inflammation in Older Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kronos Longevity Research Institute
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Oxidative stress has been linked to many diseases associated with aging, including coronary heart disease and Alzheimer's disease. Antioxidants and special proteins in the body work together to help prevent damage by free radicals. Some studies have indicated that as people age, they are less able to fight off oxidative stress and have increased levels of inflammation. Tart cherries are known to be rich in antioxidants and plant-nutrients. The product we are using in this study is an all-natural tart cherry juice, mixed with apple juice concentrate and containing no additives and no preservatives. We hope to learn whether antioxidant supplementation, such as tart cherry juice, can measurably decrease oxidative damage and inflammation associated with aging.
Detailed Description
Objectives The primary objective of this pilot study is to investigate whether tart cherry juice consumption can reduce oxidative stress in older adults as measured by attenuation of F2-isoprostane responses to a forearm ischemia-reperfusion, and a decrease in urinary excretion products of oxidative damage. The secondary objective is to examine whether age-sensitive markers of inflammation are reduced in response to the cherry juice consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Antioxidant Capacity, Inflammation
Keywords
oxidative stress, aging, ischemia-reperfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Tart Cherry Juice
Other Intervention Name(s)
CherryPharm
Intervention Description
8 fl.oz. twice per day
Primary Outcome Measure Information:
Title
plasma F2-isoprostane response to a forearm ischemia-reperfusion challenge.
Secondary Outcome Measure Information:
Title
Urinary markers of oxidative damage.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men and women, ages 55-80y, in good health, with >8 years of education non-smoker able to give informed consent Exclusion Criteria: use of anti-oxidant supplements, in excess of a standard multi-vitamins current hormone replacement therapy any history of significant chronic disease uncontrolled hypertension body mass index (BMI) > 30 kg/m2 high physical activity level, as determined by questions on the screening questionnaire use of anti-inflammatory medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tinna Traustadottir, Ph.D.
Organizational Affiliation
Kronos Longevity Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kronos Longevity Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19692530
Citation
Traustadottir T, Davies SS, Stock AA, Su Y, Heward CB, Roberts LJ 2nd, Harman SM. Tart cherry juice decreases oxidative stress in healthy older men and women. J Nutr. 2009 Oct;139(10):1896-900. doi: 10.3945/jn.109.111716. Epub 2009 Aug 19.
Results Reference
derived

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Study on Whether Tart Cherry Juice Can Reduce Oxidative Stress and Inflammation

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