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
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 April 17, 2014