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Completed

NCT Number: NCT01505348

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

QinetiQ Ltd

Farnborough, Hampshire, GU14 0LX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overnight fast

Other

Overnight fast from 21:00 h

Other names: Fasting

Primary outcomes

  1. 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

    B-CTX is a specific marker of bone resorption. It's circulating concentration is altered by both exercise and feeding

Secondary outcomes

  1. 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

    PTH is reported to induce both bone resorption and bone formation. It's circulating concentration is altered by both exercise and feeding.

Sponsors and collaborators

Lead sponsor

QinetiQ Ltd

Industry

Collaborators

  • Ministry of Defence, United Kingdom

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 6, 2012
Registry last updated
Jan 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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