Feeding PatternsNCT01505348
Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
A study testing Overnight fast in people with Feeding Patterns and Bone Resorption, run by QinetiQ Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Feeding Patterns, Bone Resorption
- What is being tested?
- Overnight fast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- smokers
- suffered a bone fracture in the previous 12 months
- musculoskeletal injury
- condition/medication known to affect bone metabolism
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Feeding Patterns, Bone Resorption
- Being tested
- Overnight fast
- Keywords
- feeding patterns, aerobic exercise, osteoclasts
- Medical subject headings
- Feeding Behavior, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overnight fastOther
Also called Fasting
Overnight fast from 21:00 h
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Overnight fast Receives: Other: Overnight fast |
| Feeding | No intervention | Normal breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
PTH is reported to induce both bone resorption and bone formation. It's circulating concentration is altered by both exercise and feeding.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding PatternsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- QinetiQ Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Defence, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Jonathan PR Scott, Ph.D, Principal investigator, QinetiQ Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505348
- Sponsor's protocol ID
- QQ-SP751
- Status last verified
- Jan 2012
- First submitted
- 4 Jan 2012
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running
- ClinicalTrials.gov ID
- NCT01505348
- Acronym / sponsor ID
- QQ-SP751
- Conditions
- Feeding Patterns, Bone Resorption
- Keywords
- feeding patterns, aerobic exercise, osteoclasts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- QinetiQ LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Defence, United Kingdom
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Other: Overnight fastOvernight fast |
| Feeding | No intervention | –Normal breakfast |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- smokers
- suffered a bone fracture in the previous 12 months
- musculoskeletal injury
- condition/medication known to affect bone metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overnight fastAlso: FastingOvernight fast from 21:00 h | Other | Fasting |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan PR Scott, Ph.D principal investigator
QinetiQ Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overnight fast in people with Feeding Patterns and Bone Resorption, run by QinetiQ Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2012.