The Effect of Pre-exercise Feeding on Bone Turnover Biomarkers
NCT ID: NCT06550466
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
16 participants
INTERVENTIONAL
2024-10-31
2025-06-30
Brief Summary
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This study will allow us to determine whether synergistic potentiating effects on bone metabolism are observed in humans in relation to the timing of food ingestion and what recommendations can be made to people with respect to food ingestion and exercise to obtain the maximal bone benefits from aerobic exercise. Furthermore, if we can identify interventions that potentiate bone's response to aerobic exercise in younger adults, then such interventions may have the ability to maximise bone mass in younger adults so that with ageing, the additional bone mineral density and improved bone microarchitecture would extend the time before osteoporotic "fracture thresholds" are reached. Therefore, understanding the bone metabolic response to exercise following fasting and feeding in younger adults is important.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Participants will undergo a baseline assessment for health history (PAR-Q). The blood samples will be collected (10ml) and osteogenic response to exercise will be determined by measuring markers of bone formation; P1NP and resorption; CTX-1 and cortisol; marker of physiological and psychological stress. Insulin and glucose measurements will allow to assess the change of concentrations in fasted and fed states.
PREVENTION
NONE
Study Groups
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Breakfast only
Breakfast only without the exercise protocol
Breakfast only
Participants will attend a breakfast-only arm without the exercise protocol.
FAST
Participants will be exercised 90 minutes following a 12-hour overnight fast
FAST
Participants will be exercised for 90 minutes following a 12-hour overnight fast
FED
Participants will be exercised 90 minutes after a meal
FED
Participants will be exercised 90 minutes after a breakfast
Interventions
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Breakfast only
Participants will attend a breakfast-only arm without the exercise protocol.
FAST
Participants will be exercised for 90 minutes following a 12-hour overnight fast
FED
Participants will be exercised 90 minutes after a breakfast
Eligibility Criteria
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Inclusion Criteria
* Caucasian ethnicity
* Aged 28 ± 4 years
* Are physically active (meet the UK guidelines for physical activity of at least 150 minutes moderate intensity activity and/or at least 75 minutes of vigorous intensity activity per week)
* Otherwise, healthy, able and willing to participate and provide written informed consent
* Have been told by medical professionals that they should not take part in moderate to high intensity exercise
* Should not be a professional athlete or take part in significant competitive recreational activity (takes no more than 4 structured exercise sessions per week on average)
* History of diagnosed eating disorders
Exclusion Criteria
* Excessive alcohol consumption (max 15 alcohol units/week)
* Any musculoskeletal injury/disabilities
* Any conditions known to affect bone metabolism (e.g. uncontrolled hyper-/hypothyroidism, hyperparathyroidism, hypo-/hypercalcaemia) or malabsorption syndromes (e.g. Crohn's disease, coeliac disease or inflammatory bowel disease).
* Taking any medication known to affect bone metabolism (such as glucocorticoids or bisphosphonates)
* Positive Covid-19 test within the last 8 weeks
* Suffered a fracture in the previous 12 months
24 Years
32 Years
MALE
Yes
Sponsors
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Anglia Ruskin University
OTHER
University of Sheffield
OTHER
Manchester Metropolitan University
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Sheffield Hallam University
OTHER
Responsible Party
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Central Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ER52048815
Identifier Type: -
Identifier Source: org_study_id
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