Impact of Diet-induced Change in Energy Balance on Metabolism in Endurance Athletes (NCT07122778) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Diet-induced Change in Energy Balance on Metabolism in Endurance Athletes
United Kingdom20 participantsStarted 2025-08
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Self-identified endurance-trained sport participants
* Training volume: \>7 hours per week endurance training
* Training frequency: at least 5 days per week
Exclusion Criteria:
* 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
* Unable to provide informed consent due to impaired cognitive capacity or decision-making ability
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resting metabolic rate (RMR) in kcal/day
Timeframe: Measured at lab visits 1-5 (baseline and pre- and post-interventions) from 0 to 12 weeks.