Effects of Acute Energy Deficit and Aerobic Exercise on Muscle Quality (NCT05203133) | Clinical Trial Compass
CompletedNot Applicable
Effects of Acute Energy Deficit and Aerobic Exercise on Muscle Quality
United Kingdom10 participantsStarted 2021-08-23
Plain-language summary
10 healthy, male, participants will complete a a 5-day baseline assessment (days -5 to -1) and two consecutive 5-day periods of controlled exercise to increase oxidative capacity (3 days of aerobic exercise per period, 15 kcal/kg FFM/day energy expenditure cycling) and energy intake (15 days in total, with a testing session on morning 16). This will achieve states of energy balance (EB; energy availability - EA - 45 kcal/kg of fat free mass (FFM)/day), required for weight maintenance (days 1 - 5), followed by energy deficit (ED; EA 10 kcal/kg FFM/day), required for weight loss on days 6 - 10.
Over the data-collection period, participants will consume deuterium (D2O) tracer to facilitate dynamic proteomic profiling to assess the impact of the intervention on muscle quality (primary outcome measure). Muscle biopsies will therefore be collected on days -5, 1, 6 \& 11, alongside daily saliva samples, and venous blood collection on days -5, 1, 3, 5, 6, 8, 10 \& 11. These samples will be used to assess further, secondary, outcome measures including alterations in intra-muscular lipid profiles (lipid droplet content, morphology and lipid-droplet associated proteins in different subcellular compartments \[intermyofibrillar vs subsarcolemmal\]), alterations in blood metabolites and hormones and skeletal muscle glycogen concentrations. Changes in body mass, body composition and RMR will also be assessed.
Who can participate
Age range
18 Years – 40 Years
Sex
MALE
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:
* Gender/Sex - Male
* Age - 18 - 40
* % body fat - \~18 - 26 %
* Health - Healthy (as determined by pre-participation questionnaires)
* Training Status - Regularly Exercising/Aerobically trained (3-4 aerobic training sessions/week, 3-5 hrs/week) Non-smokers
* Weight-stable (within 2 kg) for the past 6-months
Exclusion Criteria:
* Gender/Sex - Female/Other
* Age - \<18 - \>40
* Health - Deemed unable to perform exercise (assessed via readiness to exercise questionnaire)
* Current smoker.
* Medical Condition - Those with any previous diagnosis of; Osteoporosis/low bone mineral density, cardio-vascular disease, Diabetes Mellitus, Cerebrovascular Disease, blood-related illness/disorder, Asthma or other respiratory illness/disorder, Liver Disease, Kidney Disease, gastrointestinal disease, Eating Disorder or Disordered Eating.
* Those currently taking prescription medication or unwell with a cold or virus at the time of participation.
* Those unwilling to adhere to the study's methodological requirements (including adhering to alterations in diet and training - inc. alcohol abstention) from the day prior to intervention onset (24 hrs pre-intervention) to completion of follow-up assessments (day-11).
* Those following a restrictive diet (e.g. vegetarians/vegans)
* Any individuals with a food allergy/intolerance
* Training status - Does not train aerobically 3 + times/week (over past 6 months on average)
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.