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

Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505348
• Other study ID #: QQ-SP751
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: January 4, 2012
• Start date: July 2007
• Est. completion date: March 2008

Study information

• Verified date: January 2012
• Source: QinetiQ Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bone Resorption
• Feeding Patterns

Intervention

Other:
• Overnight fast
Overnight fast from 21:00 h

Locations

Country	Name	City	State
United Kingdom	QinetiQ Ltd	Farnborough	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
QinetiQ Ltd	Ministry of Defence, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	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	No