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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
QinetiQ Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Feeding Patterns focused on measuring feeding patterns, aerobic exercise, osteoclasts

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
January 4, 2012
Last Updated
January 4, 2012
Sponsor
QinetiQ Ltd
Collaborators
Ministry of Defence, United Kingdom
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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

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

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