NCT05773469

Brief Summary

This project is feasibility study looking at extreme exercise and possible diet intervention study to counter muscle and weight loss during a 2 person Greenland Ski Traverse in April 2023. By increasing energy intake to above the currently theoretical capacity (2.5 x RMR) the aim is to test a method to find out if there is a maximum to energy intake and whether energy deficit can be minimised; weight loss attenuated, and whether muscle can be preserved. If not, what are the likely adaptive mechanisms and use this to inform future work on dietary interventions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 28, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2023

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

March 6, 2023

Last Update Submit

January 10, 2024

Conditions

Keywords

polarultra endurancedoubly labelled waterenergy expenditureenergy intakelimit

Outcome Measures

Primary Outcomes (1)

  • body mass loss

    total amount of weight lost

    4 weeks

Secondary Outcomes (2)

  • muscle loss

    4 weeks

  • energy deficit

    4 weeks

Interventions

Ski traverse of Greenland polar Icecap

Maximising energy intake by consuming over the theoretical 2.4 x RMR

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2 persons undertaking a ski traverse across Greenland April - May 2023. 1 male and 1 female

You may qualify if:

  • \*Partaking in ski traverse across Greenland April - May 2023

You may not qualify if:

  • No neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
  • Not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Exeter, Devon, EX2 4TH, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy

Interventions

ExerciseNutritional Status

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Francis Stephens

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 17, 2023

Study Start

February 28, 2023

Primary Completion

May 25, 2023

Study Completion

November 26, 2023

Last Updated

January 11, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Data can be made available only to those listed on the collaborators list. There will be consent gained for sharing on anonymised data only.

Locations