NCT04197193

Brief 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 (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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
2.8 years until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

December 4, 2019

Last Update Submit

January 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hand grip strength

    Forearm muscle / grip strength recorded non-invasively using a hand grip dynamometer

    up to 10 months

Secondary Outcomes (3)

  • Muscle mass

    up to 10 months

  • Oxidative stress

    up to 10 months

  • Lake Louise Score 2018

    up to 10 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Over-wintering members of Concordia crew

You may qualify if:

  • Adult
  • Member of Concordia station over-wintering crew
  • Able to give written informed consent
  • Fluent in either English, French or Italian

You may not qualify if:

  • Participating in another interventional research study during the deployment to Concordia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southampton

Southampton, SO16 6YD, United Kingdom

Location

Study Officials

  • Martin Feelisch, PhD

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 13, 2019

Study Start

October 3, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations