- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281851
Examining Endogenous Antioxidant Levels in Well Trained Cyclists
August 7, 2020 updated by: University of Birmingham
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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West Midlands
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Birmingham, West Midlands, United Kingdom, B15 2TT
- School of Sport Exercise and Rehabilitation Sciences, University of Birmingham
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Cyclist from the local West Midlands (United Kingdom) area will be invited to take part in the study.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Supplemented
The group consists of well-trained cyclists who habitually consume vitamin/antioxidant supplements for a period longer than 6 months
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Non-supplemented
The group consists of well-trained cyclists who do not consume vitamin/antioxidant supplements
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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Protein concentrations will be measured at baseline only
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Aldred, MSc PhD, University of Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2013
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
October 16, 2014
First Submitted That Met QC Criteria
October 30, 2014
First Posted (Estimate)
November 4, 2014
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 7, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 125663
- 13/WM/0226 (Other Identifier: NRES Committee West Midlands - Solihull)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.