Impact of Diet-induced Change in Energy Balance on Metabolism in Endurance Athletes
Carpe DIEM
2 other identifiers
interventional
20
1 country
1
Brief Summary
Recent research has suggested that increasing levels of physical activity are associated with a reduction in the independent components that contribute to total energy expenditure (such as resting metabolic rate and non-exercise movement) - this occurs to conserve energy required for physical activity where energy provision becomes scarce. There are potential deleterious health and performance consequences of a reduced energy supply to fundamental metabolic processes, putting individuals regularly undertaking high levels of physical activity, such as endurance athletes, at risk. However, this association is largely based on observational data in only moderately active populations, and it is currently unclear what role energy balance status and biological sex has on this relationship. This research intends to address these unknowns by assessing the impact of diet-induced manipulation of energy balance (conditions of energy deficit and energy surplus) in individuals undertaking habitually high levels of physical activity on independent components of total energy expenditure (resting metabolism, exercise and non-exercise movement). Male and female athletes conducting regular moderate-to-high training volumes will undertake a randomised crossover study with a 7-day state of energy deficit and a 7-day state of energy surplus. Participants will continue to live and train as normal, but their diet will be controlled by specific food provision over the intervention periods in order to facilitate both conditions. Independent components of energy expenditure, markers of health, metabolism and performance will be measured to allow for comparison of conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
August 14, 2025
August 1, 2025
1 year
April 14, 2025
August 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resting metabolic rate (RMR) in kcal/day
The effect of a 7-day period of energy expenditure-matched diet-induced energy deficit versus energy surplus on RMR. Measured via indirect calorimetry using the Douglas bag method. Expired gas will be collected in a seated, fasted state under thermoneutral conditions, and oxygen consumption and carbon dioxide production will be used to calculate energy expenditure.
Measured at lab visits 1-5 (baseline and pre- and post-interventions) from 0 to 12 weeks.
Secondary Outcomes (36)
Total energy expenditure (from doubly labelled water) in kcal/day
Measured during both 7-day interventions starting at approximately week 4 and week 9.
Total energy expenditure ( from sum of independent components of energy expenditure) in kcal/day
Measured during both 7-day interventions starting at approximately week 4 and week 9
Peripheral blood mononuclear cell (PBMC) mitochondrial respiration
Measured pre- and post-exercise at visits 2/3 (pre- and post-intervention 1) and visits 4/5 (pre- and post-intervention 2), approximately weeks 4-12.
Sub-maximal exercise performance (during steady-state treadmill exercise)
Measured at lab visits 1-5 (baseline and pre- and post-interventions) from 0 to 12 weeks.
Free T3 in pmol/L
Measured at lab visits 2-5 (pre- and post-interventions) from 4 to 12 weeks.
- +31 more secondary outcomes
Study Arms (2)
Energy deficit
EXPERIMENTALDiet-induced 50% energy deficit (based on estimated average total daily energy expenditure) by allocation of pre-made meals and snacks over 7-days
Energy surplus
EXPERIMENTALDiet-induced energy surplus (approximately 500-1000kcal/day) achieved by allocation of additional snacks to be consumed on top of habitual free-living diet, to avoid inadvertent energy deficit
Interventions
Participants receive a prepared diet providing approximately 50% of their estimated daily energy expenditure to induce a sustained energy deficit
Participants continue their normal diet with the addition of high-calorie snack items to achieve an approximate daily energy surplus
Eligibility Criteria
You may qualify if:
- Self-identified endurance-trained sport participants
- Training volume: \>7 hours per week endurance training
- Training frequency: at least 5 days per week
You may not qualify if:
- Diagnosis of Relative Energy Deficiency in Sport (REDs)
- Active eating disorder (EDE-Q)
- Active flare of a chronic disease (e.g. inflammatory bowel disease)
- Type 1 or 2 diabetes mellitus
- Untreated or undergoing active treatment of anaemia (any cause)
- Current injury which precludes undertaking high volume endurance training
- Individuals following a habitual low-carbohydrate, high-fat diet
- Any medical diagnosis which precludes intense exercise (e.g. untreated cardiac arrhythmia)
- Allergy or intolerance to study foods
- Blood donation within preceding 8 weeks of study start date
- Use of medications that affect substrate utilisation (e.g. statins, corticosteroids, thyroxine, HRT)
- For females: current pregnancy, breastfeeding within past 6 months or post-menopausal
- Unable to undertake a treadmill running test
- Participation in any research study in the past 8 weeks
- Participation in a research study within the past year involving more than one DEXA scan
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bathlead
- Royal Centre for Defence Medicinecollaborator
Study Sites (1)
University of Bath
Bath, BA2 7AY, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2025
First Posted
August 14, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
May 1, 2027
Last Updated
August 14, 2025
Record last verified: 2025-08