Energy ExpenditureStOMPENCT05773469
Energy Balance in Extreme Environments: Finding the EI Limit
An observational study of Energy Expenditure and Atrophy, Muscular, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure, Atrophy, Muscular, Energy Intake
- What is being tested?
- Exercise and Nutrition
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2023to 26 Nov 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 2 persons undertaking a ski traverse across Greenland April - May 2023. 1 male and 1 female
Who may be able to join
- Partaking in ski traverse across Greenland April - May 2023
Who cannot join
- No neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
- Not pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Energy Expenditure, Atrophy, Muscular, Energy Intake
- Being tested
- Exercise, Nutrition
- Keywords
- polar, ultra endurance, doubly labelled water, energy expenditure, energy intake, limit
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Ski traverse of Greenland polar Icecap
NutritionOther
Maximising energy intake by consuming over the theoretical 2.4 x RMR
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass loss
total amount of weight lost
Measured: 4 weeks
Secondary outcomes (2)
muscle loss
muscle thickness loss in upper, lower limbs and trunk
Measured: 4 weeks
energy deficit
total energy deficit calculated from energy expenditure and energy intake as well as from body mass loss
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start28 Feb 2023
- Primary completion25 May 2023
- Study completion26 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy ExpenditureStudies 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
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Stephens, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773469
- Sponsor's protocol ID
- 595711
- Acronym
- StOMPE
- Status last verified
- Jan 2024
- First submitted
- 6 Mar 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be made available only to those listed on the collaborators list. There will be consent gained for sharing on anonymised data only.
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
- Energy Balance in Extreme Environments: Metabolic Adaptation to Energy Expenditure and Finding the EI Limit
- ClinicalTrials.gov ID
- NCT05773469
- Acronym / sponsor ID
- StOMPE / 595711
- Conditions
- Energy Expenditure, Atrophy, Muscular, Energy Intake
- Keywords
- polar, ultra endurance, doubly labelled water, energy expenditure, energy intake, limit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 26 Nov 2023 (actual)
- First posted
- 17 Mar 2023 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2 persons undertaking a ski traverse across Greenland April - May 2023. 1 male and 1 female
Key inclusion criteria (1 listed)
- Partaking in ski traverse across Greenland April - May 2023
Key exclusion criteria (2 listed)
- No neurological, neuromuscular, or musculoskeletal disorders that could impair the quality of the muscle. eg. CP, muscular dystrophy or SCI
- Not pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSki traverse of Greenland polar Icecap | Other | – |
| NutritionMaximising energy intake by consuming over the theoretical 2.4 x RMR | Other | – |
Primary outcome
body mass loss
Time frame: 4 weeks
total amount of weight lost
2 secondary outcomes
muscle loss
Time frame: 4 weeks
energy deficit
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No. Data can be made available only to those listed on the collaborators list. There will be consent gained for sharing on anonymised data only.
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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.
Francis Stephens principal investigator
University of Exeter
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 Energy Expenditure and Atrophy, Muscular, run by University of Exeter 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 1 inclusion and 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
body mass loss (time frame: 4 weeks). 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.