Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
| Tracking Information | |||||
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| First Received Date ICMJE | January 4, 2012 | ||||
| Last Updated Date | January 4, 2012 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in C-terminal telopeptide region of collagen type 1 (B-CTX) concentration from baseline [ Time Frame: At 08:00 h (Baseline), 09:00 h, 09:30 h, and 10:15 h (Pre-exercise), after 30 and 60 min of exercise, after 1, 2, and 3 h of recovery and at 1, 2, 3 and 4 day post-exercise ] [ Designated as safety issue: No ] B-CTX is a specific marker of bone resorption. It's circulating concentration is altered by both exercise and feeding |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Change in parathyroid hormone (PTH) concentration from baseline [ Time Frame: At 08:00 h (Baseline), 09:00 h, 09:30 h, and 10:15 h (Pre-exercise), after 30 and 60 min of exercise, after 1, 2, and 3 h of recovery and at 1, 2, 3 and 4 day post-exercise ] [ Designated as safety issue: No ] PTH is reported to induce both bone resorption and bone formation. It's circulating concentration is altered by both exercise and feeding. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running | ||||
| Official Title ICMJE | Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running | ||||
| Brief Summary | This study examined changes in bone metabolism (markers of bone turnover, calcium metabolism) with a bout of acute treadmill running preceded by either a single, mixed meal or an overnight fast. |
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| Detailed Description | Ten physically active males aged 28 ± 4 y (mean ± 1SD) completed two, counterbalanced, 8 d trials. After 3 d on a standardised diet, participants performed 60 min of treadmill running at 65% VO2max on Day 4 following an overnight fast (FAST) or a standardised breakfast (FED). Blood samples were collected at baseline, before exercise, during exercise, for 3h after exercise and on four consecutive follow-up days (FU1-FU4). Plasma/serum were analysed for β CTX, P1NP, OC, bone ALP, PTH, ACa, PO4, OPG, cortisol, leptin and ghrelin. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Overnight fast
Overnight fast from 21:00 h
Other Name: Fasting |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01505348 | ||||
| Other Study ID Numbers ICMJE | QQ-SP751 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | QinetiQ Ltd | ||||
| Study Sponsor ICMJE | QinetiQ Ltd | ||||
| Collaborators ICMJE | United Kingdom Ministry of Defence | ||||
| Investigators ICMJE |
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| Information Provided By | QinetiQ Ltd | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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