Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05773469
Other study ID # 595711
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2023
Est. completion date November 26, 2023

Study information

Verified date January 2024
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date November 26, 2023
Est. primary completion date May 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Exercise
Ski traverse of Greenland polar Icecap
Nutrition
Maximising energy intake by consuming over the theoretical 2.4 x RMR

Locations

Country Name City State
United Kingdom University Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary body mass loss total amount of weight lost 4 weeks
Secondary muscle loss muscle thickness loss in upper, lower limbs and trunk 4 weeks
Secondary energy deficit total energy deficit calculated from energy expenditure and energy intake as well as from body mass loss 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT02544009 - Quantifying the Persistence of Metabolic Adaptation and Weight Regain Following Extreme Weight Loss
Completed NCT05998096 - A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators N/A
Suspended NCT00823329 - Calorie Balance Monitoring and Analysis of Body Composition and Hydration Status Phase 0
Completed NCT01317732 - MOTIONPOD (TM) Validation and Calibration Study N/A
Completed NCT00781586 - Efficacy of ONE A DAY Weightsmart Advanced Versus Caffeine and Placebo on Energy Expenditure, Thermogenesis and Perceived Energy Levels in Women. Phase 4
Completed NCT04389736 - Effects of NMES on Energy Expenditure, Glycaemia and Hormonal Responses to Glucose Ingestion N/A
Completed NCT02272166 - Effects of Propofol on Early Recovery of Hunger After Surgery Phase 4
Completed NCT02790255 - BRown Fat Activity Measurement With Infrared imaginG tHermography andThermogenesis - the BRIGHT Study N/A
Completed NCT00995579 - Assessment of Energy Expenditure by Indirect Calorimetry for a Daily 10,000 Steps Goal N/A
Completed NCT03378115 - Energy Cost of Posture Maintenance, Ethnic Differences and the Influence of Metabolic State
Recruiting NCT06432517 - Sources and Mechanisms of Energy Compensation N/A
Not yet recruiting NCT06320951 - VITAL-IMPACT: Improving Cardiometabolic Health in Black Individuals Through Therapeutic Augmentation of Cyclic Guanosine Mono-Phosphate Signaling Pathway Phase 2
Completed NCT05412498 - Metabolic Cost of Battle Rope Training N/A
Completed NCT05412511 - Metabolic Cost of Medicine Ball Training N/A
Recruiting NCT03101215 - Workload of Water Polo Players Following a Phosphorus Manipulated High Carbohydrate Meal N/A
Completed NCT02118662 - Energy Expenditure During Seated, Seated Cycling, and Treadmill Walking Work Conditions (EE-Work) N/A
Completed NCT03602144 - Breakfast and Muscle Health in Children N/A
Completed NCT01029236 - Evaluation of Metabolism-Boosting Beverages N/A
Terminated NCT00586807 - Metabolic Response to Infliximab in Pediatric Ulcerative Colitis N/A
Completed NCT04818905 - Helichrysum Italicum Infusion Ingestion in Humans N/A