About this trial
Osteoporosis is a major contributor to loss of independence due to bone fractures and resulting hospital treatments lead to significant morbidity. While pharmacological treatments can reduce consequences of osteoporosis, there is a pressing need for non-pharmacological interventions to improve bone health across the life-course and to reduce likelihood of age-related bone disease.
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male (females excluded to remove the interplay between menstrual cycle and bone turnover)
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)
Disqualifiers
Current smokers
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).
Trial design
Crossover
Treatments tested in this trial
Breakfast only
Other interventionParticipants will attend a breakfast-only arm without the exercise protocol.
FAST
Other interventionParticipants will be exercised for 90 minutes following a 12-hour overnight fast
FED
Other interventionParticipants will be exercised 90 minutes after a breakfast
Treatment groups
Trial outcomes
Primary outcomes
C-terminal telopeptide of type-1 collagen (CTX-1)
The primary endpoint of this study is the change of the bone resorption biomarker C-terminal telopeptide of type-1 collagen (CTX-1) expression
Secondary outcomes
Procollagen type 1 N-terminal propeptide (P1NP)
The change of the bone formation biomarker procollagen type 1 N-terminal propeptide (P1NP) expression
Cortisol
Markerof physiological and psychological stress is assessed and because of its promotion of bone resorption
Insulin
The change of concentration in fasted and fed states is assessed
Glucose
The change of concentration in fasted and fed states is assessed
Locations
Sponsors and contacts
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Sheffield Hallam University
Lead sponsor
Anglia Ruskin University
Collaborator
University of Sheffield
Collaborator
Manchester Metropolitan University
Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborator
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