- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05773469
Energy Balance in Extreme Environments: Finding the EI Limit (StOMPE)
January 10, 2024 updated by: University of Exeter
Energy Balance in Extreme Environments: Metabolic Adaptation to Energy Expenditure and Finding the EI Limit
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prolonged endurance events provide a unique opportunity to study the physiological limits of human performance.
When nutrition is adequate, maintaining weight is directly related to energy expenditure.
In extreme environments however, such as ocean rowing, the investigators have shown that rowers lost 10% weight, had a high energy expenditure (5,000kcal/d or 3.1 x basal metabolic rate) which was not met by energy intake (EI).
Even in the presence of over ~5000kcal food per day, rowers chose to eat only ~3800kcal/d (2.4 x RMR) and lost weight, rather than eat more.
It is also rare, outside of elite performance, that EI is above 2.5 x RMR and is suggestive of some sort of regulatory mechanism.
Previous work has shown that high energy expenditures (EE) are not sustainable over long periods and that EE decreases with duration, plateauing at around 2.5 x RMR.
This is in attempt to balance energy requirements in order to minimise body mass loss and increase chances of survival.
Using data from the previous PhD study in ocean rowers (Holsgrove-West., 1st PhD study), and extrapolating data from the studies used to model TEE and duration, and overfeeding studies, voluntary energy intake calculated from body mass loss were consistently around 2.4 x RMR, suggesting a possible numerical value to the limit of EI.
This has not been measured experimentally.
If the theory of maximal EI is true, any intake above the maximum [2.4 x RMR] cannot be used for energy and would be excreted.
Any BM loss would therefore reflect difference between EE and the maximal EI, not the actual EI.
To investigate the EI limit therefore requires simultaneous measurements of EE, EI and body mass changes whilst ensuring EI above the theoretical maximum.In the presence of energy deficit and body mass loss, ocean rowers demonstrated an adaptive response by selectively maintaining or losing muscle.
Loaded muscles were preserved whilst unloaded muscles atrophied.
An obvious countermeasure could be to load the muscles that wasted, but to what expense?
With finite energy intake, and greater demand from the muscle mass, other components of EE such as RMR, NEAT or exercise component may compensate, or endure a greater body mass loss.
This interaction warrants further investigation.
Logistically it is difficult to ask rowers to exercise mid-race, and compliance would be unknown.
An expedition that involves greater muscle involvement and high EE is needed.
Trekking across Greenland provides the high EE environment without the lower limb disuse.
In addition, due to logistical reasons of sample storage in ocean rowing, energy expenditure and intake were collected only in the final week of the row, and energy balance did not match with body mass loss.
This would indicate a different energy deficit and different energy expenditure or intake earlier on in the row.
These initial acute changes are unknown and possibly responsible for the large weight loss seen by the end of the row.
This project will attempt to fill that gap and measure these initial changes by measuring daily EI and EE.EI is rarely measured alongside EE and body mass loss and instead inferred from EE.
This study aims to establish whether this maximal EI exists, by directly measuring both components of energy balance and how the body compensates with changes in the components of EE.
Study Type
Observational
Enrollment (Actual)
2
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
-
-
Devon
-
Exeter, Devon, United Kingdom, EX2 4TH
- University
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
2 persons undertaking a ski traverse across Greenland April - May 2023. 1 male and 1 female
Description
Inclusion Criteria:
*Partaking in ski traverse across Greenland April - May 2023
Exclusion Criteria:
- No neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
- Not pregnant
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body mass loss
Time Frame: 4 weeks
|
total amount of weight lost
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle loss
Time Frame: 4 weeks
|
muscle thickness loss in upper, lower limbs and trunk
|
4 weeks
|
|
energy deficit
Time Frame: 4 weeks
|
total energy deficit calculated from energy expenditure and energy intake as well as from body mass loss
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francis Stephens, University of Exeter
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)
February 28, 2023
Primary Completion (Actual)
May 25, 2023
Study Completion (Actual)
November 26, 2023
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Actual)
March 17, 2023
Study Record Updates
Last Update Posted (Actual)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 10, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 595711
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data can be made available only to those listed on the collaborators list.
There will be consent gained for sharing on anonymised data only.
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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