Oxidative StressNCT00847743
Study on Whether Tart Cherry Juice Can Reduce Oxidative Stress and Inflammation
A study testing Tart Cherry Juice in people with Oxidative Stress and Antioxidant Capacity, run by Kronos Longevity Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Antioxidant Capacity, Inflammation
- What is being tested?
- Tart Cherry Juice
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women, ages 55-80y, in good health, with >8 years of education
- non-smoker
- able to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kronos Longevity Research Institute
Phoenix, Arizona, 85016
About this study
Official title: Effects of Tart Cherry Juice on Oxidative Stress and Inflammation in Older Men and Women
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.
Read the 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.
- Conditions
- Oxidative Stress, Antioxidant Capacity, Inflammation
- Being tested
- Tart Cherry Juice
- Keywords
- oxidative stress, aging, ischemia-reperfusion
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart Cherry JuiceDietary supplement
Also called CherryPharm
8 fl.oz. twice per day
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma F2-isoprostane response to a forearm ischemia-reperfusion challenge.
Secondary outcomes (1)
Urinary markers of oxidative damage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startOct 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kronos Longevity Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Investigators
- Tinna Traustadottir, Ph.D., Principal investigator, Kronos Longevity Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847743
- Sponsor's protocol ID
- KLRI-2007-03
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19692530
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tart Cherry Juice on Oxidative Stress and Inflammation in Older Men and Women
- ClinicalTrials.gov ID
- NCT00847743
- Acronym / sponsor ID
- KLRI-2007-03
- Conditions
- Oxidative Stress, Antioxidant Capacity, Inflammation
- Keywords
- oxidative stress, aging, ischemia-reperfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kronos Longevity Research InstituteUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women, ages 55-80y, in good health, with >8 years of education
- non-smoker
- able to give informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tart Cherry JuiceAlso: CherryPharm8 fl.oz. twice per day | Dietary supplement | – |
Primary outcome
plasma F2-isoprostane response to a forearm ischemia-reperfusion challenge.
1 secondary outcome
Urinary markers of oxidative damage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
- Derived from this study: PubMed 19692530Traustadottir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tinna Traustadottir, Ph.D. principal investigator
Kronos Longevity Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tart Cherry Juice in people with Oxidative Stress and Antioxidant Capacity, run by Kronos Longevity Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma F2-isoprostane response to a forearm ischemia-reperfusion challenge.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2009; AzTrials last refreshed its copy on 2 Nov 2026.