Oxidative StressNCT00891488
Stress Resilience Study
An observational study of Oxidative Stress and Aging, run by Kronos Longevity Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that physiological adaptations to regular exercise training (i.e. physical fitness) attenuates age-related decline in stress resilience to both oxidative stress and the neuroendocrine responses to psychosocial stress. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Aging
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2010
- Phase
- Observational
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Men and post-menopausal women, ages 60-80 years
- Generally good health by self-report
Who cannot join
- Estrogen or testosterone supplementation within the previous 6 months
- Current smoker
- Body Mass Index (BMI) > 32 kg/m2
- Any chronic illness that could affect cortisol levels, including diabetes mellitus, liver or renal disease
- Evidence of a previous myocardial infarction within the last 6 months by EKG or history of angina or shortness of breath
- Clinically significant arrhythmia on a resting EKG or significant EKG changes during the baseline VO2max test
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- Any other condition that would contraindicate maximal exercise testing, including elevated blood pressure at rest (systolic BP >140 or diastolic BP >90 mm Hg on at least 2 measurements, at least 10 minutes apart) or musculoskeletal problems
- Depression as measured by the Beck Depression Inventory (BDI score >17)
- Use of anti-oxidant supplements, in excess of standard multi-vitamins (1 tablet/day)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kronos Longevity Research Institute
Phoenix, Arizona, 85016
About this study
Official title: Systemic and Localized Stress Resilience in Aging: Effects of Physical Fitness
The purpose of this study is to test the hypothesis that physiological adaptations to regular exercise training (i.e. physical fitness) attenuates age-related decline in stress resilience to both oxidative stress and the neuroendocrine responses to psychosocial stress.
Read the detailed description
Aging is associated with diminished stress resilience, as in reduced ability to manage or recover from acute changes in homeostasis. Increased oxidative damage to cells and tissues and dysregulation of stress hormones have been linked to age-associated chronic diseases including atherosclerosis, cancer, cardiovascular disease and Alzheimer's disease. Interventions to improve the body's resistance to stress, resulting in lower oxidative stress and better regulation of the stress hormones, may prevent or delay the onset of age-related diseases and improve quality of life.
Oxidative stress is believed to be a key mechanism in the aging process, with free radicals also implicated in many pathological processes. Similarly, dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis is thought to play a role in aging and is linked to the increased risk for age-related chronic disease.
The hormesis theory suggests that a certain amount of stress can lead to better survival and reduced tissue damage following a subsequent, more severe stress. One way to stress the system is through acute exercise. Regular exercise training, however, results in adaptive responses that increase the tolerance for successive (exercise) stress.
A relevant question is whether adaptations to regular exercise training translate to greater resilience to psychosocial stress and an increased capacity to resist acute oxidative stress, thereby providing increased protection from diseases associated with dysregulation of these systems.
This study will investigate stress resilience in two areas related to aging: oxidative stress and the neuroendocrine response to psychosocial stress. The effects of physical fitness on oxidative stress compensation and neuroendocrine stress reactivity will be determined by comparing fit and unfit older men and women. The overall aim of this study is to provide enhanced understanding of the mechanisms by which physical fitness modifies stress resilience in older men and women.
- Conditions
- Oxidative Stress, Aging
- Keywords
- VO2 max, stress, cortisol, fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fit | Not described | |
| Unfit | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
F2-isoprostane response to an oxidative challenge (forearm ischemia-reperfusion trial)
Measured: Visit 4
Cortisol response (plasma and salivary) to a psychosocial laboratory stressor--Trier Social Stress Test (TSST)
Measured: Visit 3
Secondary outcomes (3)
Total antioxidant capacity
Measured: Visit 4
ACTH response to TSST
Measured: Visit 3
Heart rate response to the TSST
Measured: Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startJul 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kronos Longevity Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Tinna Traustadóttir, PhD, Principal investigator, Kronos Longevity Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891488
- Sponsor's protocol ID
- AG0119
- Other IDs
- 1R03AG030551-01A1
- Status last verified
- Jul 2010
- First submitted
- 30 Apr 2009
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Traustadottir T, Bosch PR, Matt KS. The HPA axis response to stress in women: effects of aging and fitness. Psychoneuroendocrinology. 2005 May;30(4):392-402. doi: 10.1016/j.psyneuen.2004.11.002. Epub 2005 Jan 11.
PubMed 15694119Fatouros IG, Jamurtas AZ, Villiotou V, Pouliopoulou S, Fotinakis P, Taxildaris K, Deliconstantinos G. Oxidative stress responses in older men during endurance training and detraining. Med Sci Sports Exerc. 2004 Dec;36(12):2065-72. doi: 10.1249/01.mss.0000147632.17450.ff.
PubMed 15570141Vincent HK, Bourguignon C, Vincent KR. Resistance training lowers exercise-induced oxidative stress and homocysteine levels in overweight and obese older adults. Obesity (Silver Spring). 2006 Nov;14(11):1921-30. doi: 10.1038/oby.2006.224.
PubMed 17135607Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.
PubMed 11089981
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic and Localized Stress Resilience in Aging: Effects of Physical Fitness
- ClinicalTrials.gov ID
- NCT00891488
- Acronym / sponsor ID
- AG0119
- Conditions
- Oxidative Stress, Aging
- Keywords
- VO2 max, stress, cortisol, fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kronos Longevity Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 May 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.
The purpose of this study is to test the hypothesis that physiological adaptations to regular exercise training (i.e. physical fitness) attenuates age-related decline in stress resilience to both oxidative stress and the neuroendocrine responses to psychosocial stress.
Detailed description
Aging is associated with diminished stress resilience, as in reduced ability to manage or recover from acute changes in homeostasis. Increased oxidative damage to cells and tissues and dysregulation of stress hormones have been linked to age-associated chronic diseases including atherosclerosis, cancer, cardiovascular disease and Alzheimer's disease. Interventions to improve the body's resistance to stress, resulting in lower oxidative stress and better regulation of the stress hormones, may prevent or delay the onset of age-related diseases and improve quality of life.
Oxidative stress is believed to be a key mechanism in the aging process, with free radicals also implicated in many pathological processes. Similarly, dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis is thought to play a role in aging and is linked to the increased risk for age-related chronic disease.
The hormesis theory suggests that a certain amount of stress can lead to better survival and reduced tissue damage following a subsequent, more severe stress. One way to stress the system is through acute exercise. Regular exercise training, however, results in adaptive responses that increase the tolerance for successive (exercise) stress.
A relevant question is whether adaptations to regular exercise training translate to greater resilience to psychosocial stress and an increased capacity to resist acute oxidative stress, thereby providing increased protection from diseases associated with dysregulation of these systems.
This study will investigate stress resilience in two areas related to aging: oxidative stress and the neuroendocrine response to psychosocial stress. The effects of physical fitness on oxidative stress compensation and neuroendocrine stress reactivity will be determined by comparing fit and unfit older men and women. The overall aim of this study is to provide enhanced understanding of the mechanisms by which physical fitness modifies stress resilience in older men and women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fit | – | – |
| Unfit | – | – |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Men and post-menopausal women, ages 60-80 years
- Generally good health by self-report
Key exclusion criteria (9 listed)
- Estrogen or testosterone supplementation within the previous 6 months
- Current smoker
- Body Mass Index (BMI) > 32 kg/m2
- Any chronic illness that could affect cortisol levels, including diabetes mellitus, liver or renal disease
- Evidence of a previous myocardial infarction within the last 6 months by EKG or history of angina or shortness of breath
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
F2-isoprostane response to an oxidative challenge (forearm ischemia-reperfusion trial)
Time frame: Visit 4
Cortisol response (plasma and salivary) to a psychosocial laboratory stressor--Trier Social Stress Test (TSST)
Time frame: Visit 3
3 secondary outcomes
Total antioxidant capacity
Time frame: Visit 4
ACTH response to TSST
Time frame: Visit 3
Heart rate response to the TSST
Time frame: Visit 3
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 3 Aug 2010.
- Background: PubMed 15694119Traustadottir T, Bosch PR, Matt KS. The HPA axis response to stress in women: effects of aging and fitness. Psychoneuroendocrinology. 2005 May;30(4):392-402. doi: 10.1016/j.psyneuen.2004.11.002. Epub 2005 Jan 11.
- Background: PubMed 15570141Fatouros IG, Jamurtas AZ, Villiotou V, Pouliopoulou S, Fotinakis P, Taxildaris K, Deliconstantinos G. Oxidative stress responses in older men during endurance training and detraining. Med Sci Sports Exerc. 2004 Dec;36(12):2065-72. doi: 10.1249/01.mss.0000147632.17450.ff.
- Background: PubMed 17135607Vincent HK, Bourguignon C, Vincent KR. Resistance training lowers exercise-induced oxidative stress and homocysteine levels in overweight and obese older adults. Obesity (Silver Spring). 2006 Nov;14(11):1921-30. doi: 10.1038/oby.2006.224.
- Background: PubMed 11089981Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.
- Kronos Longevity Research InstituteLink provided by the sponsor.
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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 Traustadóttir, PhD 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?
An observational study of Oxidative Stress and Aging, 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 2 inclusion and 9 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 3 Aug 2010. 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?
F2-isoprostane response to an oxidative challenge (forearm ischemia-reperfusion trial) (time frame: Visit 4). The study lists 2 primary outcomes in all. 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 NCT00891488, which also lists 4 linked publications.
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 3 Aug 2010; AzTrials last refreshed its copy on 28 Oct 2026.