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| Name | Class |
|---|---|
| Anglia Ruskin University | OTHER |
| University of Sheffield | OTHER |
| Manchester Metropolitan University | OTHER |
| Sheffield Teaching Hospitals NHS Foundation Trust |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breakfast only | Experimental | Breakfast only without the exercise protocol |
|
| FAST | Experimental | Participants will be exercised 90 minutes following a 12-hour overnight fast |
|
| FED | Experimental | Participants will be exercised 90 minutes after a meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breakfast only | Other | Participants will attend a breakfast-only arm without the exercise protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Between pre-exercise and 2 hours following the exercise timepoints |
| Measure | Description | Time Frame |
|---|---|---|
| Procollagen type 1 N-terminal propeptide (P1NP) | The change of the bone formation biomarker procollagen type 1 N-terminal propeptide (P1NP) expression | Between pre-exercise and 2 hours following the exercise timepoints |
| Cortisol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon Bowles, PhD | Contact | 00441142254216 | s.bowles@shu.ac.uk | |
| Jasmine Samvelyan, PhD | Contact | jasmine.samvelyan@aru.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2024 | Aug 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
In this three-arm randomised crossover study, sixteen young adult men (age: 28 ± 4) will be recruited in good physical condition. Participants will be exercised following a 12-hour overnight fast (FAST) and exercised 90 minutes after a meal (FED) to test the temporal sensitivity of the loaded bone to absorbed nutrients. Participants will also attend a breakfast-only arm (without the exercise protocol).
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.
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| FAST | Other | Participants will be exercised for 90 minutes following a 12-hour overnight fast |
|
| FED | Other | Participants will be exercised 90 minutes after a breakfast |
|
Markerof physiological and psychological stress is assessed and because of its promotion of bone resorption
| Between pre-exercise and 2 hours following the exercise timepoints |
| Insulin | The change of concentration in fasted and fed states is assessed | Between pre-exercise and 2 hours following the exercise timepoints |
| Glucose | The change of concentration in fasted and fed states is assessed | Between pre-exercise and 2 hours following the exercise timepoints |