Oxidative StressNCT01296490
Physical Fitness Effect on the Different Oxidative Stress Measurements
A study testing Stress test in people with Oxidative Stress, run by Wingate Institute at 1 site in Israel.
Trial summary
Physical exercise has many benefits, although it might also have negative impact on the body, which changes in accordance with training level, length of workout, age of subject and their fitness level. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Stress test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to May 2012
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- 20-35 years of age, with 6-24% body fat.
Who cannot join
- Smokers and subjects who use vitamins and supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Physical Fitness Effect on the Different Oxidative Stress Measurements, at Rest and After Acute Exercise
Physical exercise has many benefits, although it might also have negative impact on the body, which changes in accordance with training level, length of workout, age of subject and their fitness level. These outcomes are governed by complex biological processes, from which Reactive Oxygen Substances (ROS) are considered the most prominent ones during exercise activity. These substances harm muscle activity, and might cause other health related damage by influencing other pathways that engage with free radicals. Excess of ROS, is expressed as Oxidative Stress (OS), pathogenic process activation and aging. With this in mind, it is important to remember that ROS are essential to the investigators bodies as well, especially in gene regulation. Thus they influence proteins that are important for proper muscle function and the immune system.
Physical exercise induces changes in low molecular weight antioxidants, and in antioxidant enzymes. According to results that were published in the literature, no universal conclusion can be made regarding physical exercise effect on antioxidants activity. These contradictions might be attributed to the difference between the methods that were used, and their quality.
Read more
Paradoxically, physical exercise has the same effect on ROS inducement in skeletal muscle fibers as does not using the muscles for a long period of time (especially as a result of handicap). It is well known that physical exercise effect oxidative stress and antioxidant. Due to the doubts that rise from the literature, the investigators think that it is important to test physical fitness effect on oxidative stress biological markers, using various high quality methods, on the same population.
The investigators will test healthy men, 20-35 years of age, none smokers with 6-24% fat, who do not take vitamins or supplements. The men will run on a treadmill for 10 minutes to exhaustion, and blood will be taken before the test, 5 minutes after the test, and an hour after the test (checking recovery).
Read the detailed description
Things the investigators will measure:
- Filling out a physical fitness, and overall health form, that indicates all fitness activity in the past 3 years, and vitamins and supplements that are being taken.
- Fat percentage
- VO2 max
- Oxidants and antioxidants activity: Super oxide dismutase, Catalase, GSH/GSSG, Glutathione peroxide, Glutathione reductase, LDL, conjugated dienes, Plasma malondialdehyde. Measurements will be taken before the test, 5 minutes after the test and an hour after the test.
Work plan:
50 men, at the ages of 20-35 will be recruited. The participants will fill out a form that indicates their physical activity in the past 3 years, as well as their vitamin and supplements intake.
The men will run on a treadmill for 10 minutes until exhaustion.
Blood will be drawn before, 5 minutes after and an hour after the test. Oxidative stress will be measured according to the following parameters:
- 10 ml of blood in citrate tube will be centrifuged and analyzed for: Super oxide dismutase, Catalase, GSH/GSSG, Glutathione peroxide, Glutathione reductase.
- 2 ml of blood with no coagulating factors will be centrifuged and analyzed for: LDL, conjugated dienes, Plasma malondialdehyde (TBARS).
Clinical research:
Participants will run on a treadmill for 10 minutes until exhaustion. The men will be divided into 5 groups according to their VO2 max, comparing the oxidants and antioxidants activity between the groups.
Checking the oxidative stress and VO2 dependency (VO2 is an index for physical fitness).
Age: 20-35 Sex: Men Inclusion criteria: Healthy men, 2-35 years of age, with 6-24% body fat. Exclusion criteria: Smokers, and people who use vitamins and supplements.
- Conditions
- Oxidative Stress
- Being tested
- Stress test
- Keywords
- oxidative stress, physical exercise, fitness level
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress testOther
Also called blood test
Stress test while running on a treadmill until exhaustion for 8-12 minutes. Blood will be drawn before, 5 minutes after and an hour after the test.
| Study group | Role | What they receive |
|---|---|---|
| Stress test | Experimental | The men will run on a treadmill for 10 minutes until exhaustion. Blood will be drawn before, 5 minutes after and an hour after the test. Receives: Other: Stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher increase in oxidative stress inducing factors, and antioxidants in men with lower physical fitness compared with men with higher physical fitness.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wingate Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Dr. Eyal Shargal, Wingate Institute
- Investigators
- Dov Lichtenberg, PhD, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296490
- Sponsor's protocol ID
- Wingate 05
- Status last verified
- Dec 2013
- First submitted
- 3 Feb 2011
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Physical Fitness Effect on the Different Oxidative Stress Measurements, at Rest and After Acute Exercise
- ClinicalTrials.gov ID
- NCT01296490
- Acronym / sponsor ID
- Wingate 05
- Conditions
- Oxidative Stress
- Keywords
- oxidative stress, physical exercise, fitness level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wingate InstituteUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Feb 2011 (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.
Physical exercise has many benefits, although it might also have negative impact on the body, which changes in accordance with training level, length of workout, age of subject and their fitness level. These outcomes are governed by complex biological processes, from which Reactive Oxygen Substances (ROS) are considered the most prominent ones during exercise activity. These substances harm muscle activity, and might cause other health related damage by influencing other pathways that engage with free radicals. Excess of ROS, is expressed as Oxidative Stress (OS), pathogenic process activation and aging. With this in mind, it is important to remember that ROS are essential to the investigators bodies as well, especially in gene regulation. Thus they influence proteins that are important for proper muscle function and the immune system.
Physical exercise induces changes in low molecular weight antioxidants, and in antioxidant enzymes. According to results that were published in the literature, no universal conclusion can be made regarding physical exercise effect on antioxidants activity. These contradictions might be attributed to the difference between the methods that were used, and their quality.
Paradoxically, physical exercise has the same effect on ROS inducement in skeletal muscle fibers as does not using the muscles for a long period of time (especially as a result of handicap). It is well known that physical exercise effect oxidative stress and antioxidant. Due to the doubts that rise from the literature, the investigators think that it is important to test physical fitness effect on oxidative stress biological markers, using various high quality methods, on the same population.
The investigators will test healthy men, 20-35 years of age, none smokers with 6-24% fat, who do not take vitamins or supplements. The men will run on a treadmill for 10 minutes to exhaustion, and blood will be taken before the test, 5 minutes after the test, and an hour after the test (checking recovery).
Detailed description
Things the investigators will measure:
- Filling out a physical fitness, and overall health form, that indicates all fitness activity in the past 3 years, and vitamins and supplements that are being taken.
- Fat percentage
- VO2 max
- Oxidants and antioxidants activity: Super oxide dismutase, Catalase, GSH/GSSG, Glutathione peroxide, Glutathione reductase, LDL, conjugated dienes, Plasma malondialdehyde. Measurements will be taken before the test, 5 minutes after the test and an hour after the test.
Work plan:
50 men, at the ages of 20-35 will be recruited. The participants will fill out a form that indicates their physical activity in the past 3 years, as well as their vitamin and supplements intake.
The men will run on a treadmill for 10 minutes until exhaustion.
Blood will be drawn before, 5 minutes after and an hour after the test. Oxidative stress will be measured according to the following parameters:
- 10 ml of blood in citrate tube will be centrifuged and analyzed for: Super oxide dismutase, Catalase, GSH/GSSG, Glutathione peroxide, Glutathione reductase.
- 2 ml of blood with no coagulating factors will be centrifuged and analyzed for: LDL, conjugated dienes, Plasma malondialdehyde (TBARS).
Clinical research:
Participants will run on a treadmill for 10 minutes until exhaustion. The men will be divided into 5 groups according to their VO2 max, comparing the oxidants and antioxidants activity between the groups.
Checking the oxidative stress and VO2 dependency (VO2 is an index for physical fitness).
Age: 20-35 Sex: Men Inclusion criteria: Healthy men, 2-35 years of age, with 6-24% body fat. Exclusion criteria: Smokers, and people who use vitamins and supplements.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress test | Experimental | Other: Stress testThe men will run on a treadmill for 10 minutes until exhaustion. Blood will be drawn before, 5 minutes after and an hour after the test. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men
- 20-35 years of age, with 6-24% body fat.
Key exclusion criteria (1 listed)
- Smokers and subjects who use vitamins and supplements
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 |
|---|---|---|
| Stress testAlso: blood testStress test while running on a treadmill until exhaustion for 8-12 minutes. Blood will be drawn before, 5 minutes after and an hour after the test. | Other | Stress test |
Primary outcome
Higher increase in oxidative stress inducing factors, and antioxidants in men with lower physical fitness compared with men with higher physical fitness.
Time frame: one year
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 1 Jan 2014.
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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.
Dov Lichtenberg, PhD study chair
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress test in people with Oxidative Stress, run by Wingate Institute at 1 site in Israel.
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 1 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 1 Jan 2014. 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 Israel. 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?
Higher increase in oxidative stress inducing factors, and antioxidants in men with lower physical fitness compared with men with higher physical fitness. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2014.