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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00847743
Other study ID # KLRI-2007-03
Secondary ID
Status Completed
Phase N/A
First received February 17, 2009
Last updated February 18, 2009
Start date October 2007
Est. completion date April 2008

Study information

Verified date February 2009
Source Kronos Longevity Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Tart Cherry Juice
8 fl.oz. twice per day

Locations

Country Name City State
United States Kronos Longevity Research Institute Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Kronos Longevity Research Institute Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma F2-isoprostane response to a forearm ischemia-reperfusion challenge. No
Secondary Urinary markers of oxidative damage. No
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