NCT01505348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2012

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

January 4, 2012

Last Update Submit

January 4, 2012

Conditions

Feeding PatternsBone Resorption

Keywords

feeding patternsaerobic exerciseosteoclasts

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (1)

  • Change in parathyroid hormone (PTH) concentration from baseline

    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

Study Arms (2)

Fasting

EXPERIMENTAL

Overnight fast

Other: Overnight fast

Feeding

NO INTERVENTION

Normal breakfast

Interventions

Overnight fastOTHER

Overnight fast from 21:00 h

Also known as: Fasting
Fasting

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QinetiQ Ltd

Farnborough, Hampshire, GU14 0LX, United Kingdom

Location

MeSH Terms

Conditions

Feeding BehaviorBone Resorption

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorBone DiseasesMusculoskeletal Diseases

Study Officials

  • Jonathan PR Scott, Ph.D

    QinetiQ Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 6, 2012

Study Start

July 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

GB(1)