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

This study has been completed.
Sponsor:
Collaborator:
United Kingdom Ministry of Defence
Information provided by (Responsible Party):
QinetiQ Ltd
ClinicalTrials.gov Identifier:
NCT01505348
First received: January 4, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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 Intervention
Feeding Patterns
Bone Resorption
Other: Overnight fast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running

Further study details as provided by QinetiQ Ltd:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: July 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasting
Overnight fast
Other: Overnight fast
Overnight fast from 21:00 h
Other Name: Fasting
No Intervention: Feeding
Normal breakfast

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505348

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

No publications provided

Responsible Party: QinetiQ Ltd
ClinicalTrials.gov Identifier: NCT01505348     History of Changes
Other Study ID Numbers: QQ-SP751
Study First Received: January 4, 2012
Last Updated: January 4, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by QinetiQ Ltd:
feeding patterns
aerobic exercise
osteoclasts

Additional relevant MeSH terms:
Bone Resorption
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014