- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04197193
Monitoring Antioxidant/Redox Status at Concordia (MARS-C) (MARS-C)
January 9, 2024 updated by: University of Southampton
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Martin Feelisch, PhD
- Phone Number: 023 8120 6891
- Email: m.feelisch@soton.ac.uk
Study Contact Backup
- Name: Andrew Cumpstey, BM BCh
- Phone Number: 023 8120 5308
- Email: a.cumpstey@soton.ac.uk
Study Locations
-
-
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Southampton, United Kingdom, SO16 6YD
- University of Southampton
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Over-wintering members of Concordia crew
Description
Inclusion Criteria:
- Adult
- Member of Concordia station over-wintering crew
- Able to give written informed consent
- Fluent in either English, French or Italian
Exclusion Criteria:
- Participating in another interventional research study during the deployment to Concordia
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand grip strength
Time Frame: up to 10 months
|
Forearm muscle / grip strength recorded non-invasively using a hand grip dynamometer
|
up to 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle mass
Time Frame: up to 10 months
|
cross sectional forearm muscle area recorded a standardised way using medical ultrasound
|
up to 10 months
|
Oxidative stress
Time Frame: up to 10 months
|
Nitrate, nitrite, nitroso species, FRAP, TFTs, glutathione ratios, 8-isoprostane,
|
up to 10 months
|
Lake Louise Score 2018
Time Frame: up to 10 months
|
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
|
up to 10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Feelisch, PhD, University of Southampton
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)
October 3, 2022
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 4, 2019
First Submitted That Met QC Criteria
December 11, 2019
First Posted (Actual)
December 13, 2019
Study Record Updates
Last Update Posted (Estimated)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 9, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 49348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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