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Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running

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ClinicalTrials.gov Identifier: NCT01505348
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : January 6, 2012
Sponsor:
Collaborator:
Ministry of Defence, United Kingdom
Information provided by (Responsible Party):
QinetiQ Ltd

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.

Condition or disease Intervention/treatment Phase
Feeding Patterns Bone Resorption Other: Overnight fast Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: Fasting
Overnight fast
Other: Overnight fast
Overnight fast from 21:00 h
Other Name: Fasting
No Intervention: Feeding
Normal breakfast



Primary Outcome Measures :
  1. 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 ]
    B-CTX is a specific marker of bone resorption. It's circulating concentration is altered by both exercise and feeding


Secondary Outcome Measures :
  1. 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 ]
    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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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • history of weight bearing exercise
  • fasting vitamin D concentration of >30 nmol•L-1 and/or a fasting parathyroid hormone (PTH) concentration of <6.9 pmol•L-1.

Exclusion Criteria:

  • smokers
  • suffered a bone fracture in the previous 12 months
  • musculoskeletal injury
  • condition/medication known to affect bone metabolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505348


Locations
United Kingdom
QinetiQ Ltd
Farnborough, Hampshire, United Kingdom, GU14 0LX
Sponsors and Collaborators
QinetiQ Ltd
Ministry of Defence, United Kingdom
Investigators
Principal Investigator: Jonathan PR Scott, Ph.D QinetiQ Ltd

Responsible Party: QinetiQ Ltd
ClinicalTrials.gov Identifier: NCT01505348     History of Changes
Other Study ID Numbers: QQ-SP751
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Keywords provided by QinetiQ Ltd:
feeding patterns
aerobic exercise
osteoclasts

Additional relevant MeSH terms:
Bone Resorption
Bone Diseases
Musculoskeletal Diseases