Oxidative StressMARS-CNCT04197193
Monitoring Antioxidant/Redox Status at Concordia (MARS-C)
An observational study of Oxidative Stress, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The European Space Agency (ESA) runs a research centre in Antarctica as an earth-based model for long duration deep-space missions. Just like astronauts travelling into space, crew-members overwintering at this Concordia base are exposed to a number of extreme environmental stressors; including high altitude… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2022to Dec 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Over-wintering members of Concordia crew
Who may be able to join
- Adult
- Member of Concordia station over-wintering crew
- Able to give written informed consent
- Fluent in either English, French or Italian
Who cannot join
- Participating in another interventional research study during the deployment to Concordia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Antioxidant/Redox Status and Replenishing Nitrogen & Sulfur-based Nutrients to Enhance Resilience at Concordia (MARS-C): Understanding Integrated Stress Signalling
The European Space Agency (ESA) runs a research centre in Antarctica as an earth-based model for long duration deep-space missions. Just like astronauts travelling into space, crew-members overwintering at this Concordia base are exposed to a number of extreme environmental stressors; including high altitude (approximately 3800m); extreme cold; long periods of 24 hour darkness or daylight; and complete isolation. The investigators will recruit up to 30 over-wintering crew members working at this station for ESA over a 2 year period and observe how their bodies adapt and respond to the stress of living and working in this environment. The investigators will collect blood, saliva and urine samples, together with ultrasound images of muscle mass and grip strength measurements at regular intervals throughout their deployment to Antarctica. These samples will be transported back to Southampton to be analysed for biochemical levels of stress. During the final month of their stay, all participants will be randomised to receive a daily nutritional drink which is either high or low in targeted dietary supplements. Following similar studies that the investigators has successfully performed over shorter durations at high altitudes previously, they hypothesise that levels of stress experienced in extreme environments such as Antarctica or deep space can be reduced with targeted nutritional supplementation. These findings may become important to members of the general public as commercial aviation moves increasingly towards using low space-orbital vehicles to drastically reduce international travel times over the coming decade.
- Conditions
- Oxidative Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Forearm muscle / grip strength recorded non-invasively using a hand grip dynamometer
Measured: up to 10 months
Secondary outcomes (3)
Muscle mass
cross sectional forearm muscle area recorded a standardised way using medical ultrasound
Measured: up to 10 months
Oxidative stress
Nitrate, nitrite, nitroso species, FRAP, TFTs, glutathione ratios, 8-isoprostane,
Measured: up to 10 months
Lake Louise Score 2018
A validated measure of altitude related symptoms and illness which scores symptoms across 4 different domains: headache, GI disturbance, fatigue \& dizziness. Each is scored from 0 - 3 (for no symptoms to very debilitating respectively) and a total score of 3 or more including at headache symptoms is required for a positive diagnosis of Acute Mountain Sickness
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start3 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- European Space Agency
- Responsible party
- Sponsor
- Investigators
- Martin Feelisch, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197193
- Sponsor's protocol ID
- 49348
- Acronym
- MARS-C
- Status last verified
- Jan 2024
- First submitted
- 4 Dec 2019
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Antioxidant/Redox Status and Replenishing Nitrogen & Sulfur-based Nutrients to Enhance Resilience at Concordia (MARS-C): Understanding Integrated Stress Signalling
- ClinicalTrials.gov ID
- NCT04197193
- Acronym / sponsor ID
- MARS-C / 49348
- Conditions
- Oxidative Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- European Space Agency
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Dec 2019 (actual)
- 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 European Space Agency (ESA) runs a research centre in Antarctica as an earth-based model for long duration deep-space missions. Just like astronauts travelling into space, crew-members overwintering at this Concordia base are exposed to a number of extreme environmental stressors; including high altitude (approximately 3800m); extreme cold; long periods of 24 hour darkness or daylight; and complete isolation. The investigators will recruit up to 30 over-wintering crew members working at this station for ESA over a 2 year period and observe how their bodies adapt and respond to the stress of living and working in this environment. The investigators will collect blood, saliva and urine samples, together with ultrasound images of muscle mass and grip strength measurements at regular intervals throughout their deployment to Antarctica. These samples will be transported back to Southampton to be analysed for biochemical levels of stress. During the final month of their stay, all participants will be randomised to receive a daily nutritional drink which is either high or low in targeted dietary supplements. Following similar studies that the investigators has successfully performed over shorter durations at high altitudes previously, they hypothesise that levels of stress experienced in extreme environments such as Antarctica or deep space can be reduced with targeted nutritional supplementation. These findings may become important to members of the general public as commercial aviation moves increasingly towards using low space-orbital vehicles to drastically reduce international travel times over the coming decade.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Over-wintering members of Concordia crew
Key inclusion criteria (4 listed)
- Adult
- Member of Concordia station over-wintering crew
- Able to give written informed consent
- Fluent in either English, French or Italian
Key exclusion criteria (1 listed)
- Participating in another interventional research study during the deployment to Concordia
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
Hand grip strength
Time frame: up to 10 months
Forearm muscle / grip strength recorded non-invasively using a hand grip dynamometer
3 secondary outcomes
Muscle mass
Time frame: up to 10 months
Oxidative stress
Time frame: up to 10 months
Lake Louise Score 2018
Time frame: up to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Martin Feelisch, PhD principal investigator
University of Southampton
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 Southampton 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 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. 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?
Results are not available in the source record.
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?
Hand grip strength (time frame: up to 10 months). 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 Jan 2024.