Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
Primary Purpose
Feeding Patterns, Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Overnight fast
Sponsored by
About this trial
This is an interventional basic science trial for Feeding Patterns focused on measuring feeding patterns, aerobic exercise, osteoclasts
Eligibility 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
Sites / Locations
- QinetiQ Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fasting
Feeding
Arm Description
Overnight fast
Normal breakfast
Outcomes
Primary Outcome Measures
Change in C-terminal telopeptide region of collagen type 1 (B-CTX) concentration from baseline
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
PTH is reported to induce both bone resorption and bone formation. It's circulating concentration is altered by both exercise and feeding.
Full Information
NCT ID
NCT01505348
First Posted
January 4, 2012
Last Updated
January 4, 2012
Sponsor
QinetiQ Ltd
Collaborators
Ministry of Defence, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01505348
Brief Title
Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
Official Title
Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QinetiQ Ltd
Collaborators
Ministry of Defence, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Patterns, Bone Resorption
Keywords
feeding patterns, aerobic exercise, osteoclasts
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fasting
Arm Type
Experimental
Arm Description
Overnight fast
Arm Title
Feeding
Arm Type
No Intervention
Arm Description
Normal breakfast
Intervention Type
Other
Intervention Name(s)
Overnight fast
Other Intervention Name(s)
Fasting
Intervention Description
Overnight fast from 21:00 h
Primary Outcome Measure Information:
Title
Change in C-terminal telopeptide region of collagen type 1 (B-CTX) concentration from baseline
Description
B-CTX is a specific marker of bone resorption. It's circulating concentration is altered by both exercise and feeding
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
Secondary Outcome Measure Information:
Title
Change in parathyroid hormone (PTH) concentration from baseline
Description
PTH is reported to induce both bone resorption and bone formation. It's circulating concentration is altered by both exercise and feeding.
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan PR Scott, Ph.D
Organizational Affiliation
QinetiQ Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
QinetiQ Ltd
City
Farnborough
State/Province
Hampshire
ZIP/Postal Code
GU14 0LX
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
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