Oxidative StressNCT02281851
Examining Endogenous Antioxidant Levels in Well Trained Cyclists
An observational study of Oxidative Stress, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to May 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Cyclist from the local West Midlands (United Kingdom) area will be invited to take part in the study.
Who may be able to join
- Male,
- BMI 18.8 29.9 kg/m2
- cycle 3-7 times a week for durations longer than 60 minutes
- cycled for a minimum of 3 years
- accustomed to exhaustive cycling protocols
- healthy (no known cardiovascular or metabolic disease)
Who cannot join
- answering "NO" to any question on the general health questionnaire would result in exclusion from the study
- current participation in another clinical study
- current or recent smoker (last 30 days)
- prescription or non-prescription of anti-inflammatory use >30 days prior to the experiment commencing or any other medications that in the opinion of the investigator may interfere with redox signalling
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, West Midlands, B15 2TT
About this study
Official title: The Effects of Habitual Antioxidant Supplementation on Endogenous Antioxidants and Oxidative Damage in Well Trained Cyclists
This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group.
- Conditions
- Oxidative Stress
- Keywords
- Endogenous antioxidants, Antioxidant supplements, Vitamin Supplements, Exercise adaptations, Oxidative stress, Redox regulation, Cycling - exercise
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 |
|---|---|---|
| Supplemented | The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months | |
| Non-supplemented | The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)
To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations
Measured: Protein concentrations will be measured at baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startJul 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Aldred, MSc PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281851
- Sponsor's protocol ID
- 125663
- Other IDs
- 13/WM/0226
- Status last verified
- Aug 2020
- First submitted
- 16 Oct 2014
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Habitual Antioxidant Supplementation on Endogenous Antioxidants and Oxidative Damage in Well Trained Cyclists
- ClinicalTrials.gov ID
- NCT02281851
- Acronym / sponsor ID
- 125663
- Conditions
- Oxidative Stress
- Keywords
- Endogenous antioxidants, Antioxidant supplements, Vitamin Supplements, Exercise adaptations, Oxidative stress, Redox regulation, Cycling - exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Posted 15 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether increased habitual intake of antioxidant supplements effects the concentration of endogenous antioxidants, the response of antioxidants to exercise, and differences in oxidative damage compared to a non-supplemented group.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemented | – | –The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months |
| Non-supplemented | – | –The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cyclist from the local West Midlands (United Kingdom) area will be invited to take part in the study.
Key inclusion criteria (6 listed)
- Male,
- BMI 18.8 29.9 kg/m2
- cycle 3-7 times a week for durations longer than 60 minutes
- cycled for a minimum of 3 years
- accustomed to exhaustive cycling protocols
Key exclusion criteria (4 listed)
- answering "NO" to any question on the general health questionnaire would result in exclusion from the study
- current participation in another clinical study
- current or recent smoker (last 30 days)
- prescription or non-prescription of anti-inflammatory use >30 days prior to the experiment commencing or any other medications that in the opinion of the investigator may interfere with redox signalling
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
Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)
Time frame: Protein concentrations will be measured at baseline only
To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sarah Aldred, MSc PhD principal investigator
University of Birmingham
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, run by University of Birmingham at 1 site in United Kingdom.
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 6 inclusion and 4 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 11 Aug 2020. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2) (time frame: Protein concentrations will be measured at baseline only). 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 11 Aug 2020.