Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000675628
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
26/06/2014
Date last updated
26/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a high calcium pre-event meal on biomarkers of calcium homeostasis in female cyclists
Scientific title
The effects of a calcium-rich pre-exercise meal on Cross Linked C-Telopeptide of Type I Collagen (CTX-I), Cross Linked C-Telopeptide of Type II Collagen (CTX-II), Parathyroid Hormone (PTH), and bone formation (Procollagen I N-Terminal Propeptide (PINP) in competitive female cyclists.
Secondary ID [1] 284823 0
Nil Known
Universal Trial Number (UTN)
U1111-1158-1577
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia (prevention) 292208 0
Oestoporosis (prevention) 292209 0
Condition category
Condition code
Musculoskeletal 292543 292543 0 0
Osteoporosis
Diet and Nutrition 292609 292609 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cyclists completed two 90 min cycling trials (80 min at 60% maximal aerobic power followed by a 10 min maximal time trial) separated by 1 day. Exercise trials were preceded 2 h by either a calcium-rich (mean +/- SD; 1352 +/- 53 mg calcium) dairy based meal or a control meal (46 +/- 7 mg calcium). The calcium-rich meal consisted of rolled-oats cooked with calcium-fortified (Tricalcium phosphate, Nano-calcium) milk, yoghurt and additional milk.
Intervention code [1] 289616 0
Prevention
Comparator / control treatment
The control meal provided oats cooked with water and served with tinned fruit and nuts. The calcium content was 46 +/- 7 mg.
Control group
Active

Outcomes
Primary outcome [1] 292411 0
The primary outcome of this study was the effects of a calcium pre-exercise meal on the exercise induced changes in bone turnover (formation and resoprtion). This was measured as the average serum concentration of Cross Linked C-Telopeptide of Type I Collagen (CTX-I), Cross Linked C-Telopeptide of Type II Collagen (CTX-II), Parathyroid Hormone (PTH), and bone formation (Procollagen I N-Terminal Propeptide (PINP) measured using Enzyme-Linked immunoSorbent Assay (ELISA)
Timepoint [1] 292411 0
pre-trial (time = 0 min); pre-exercise (t = 115 min); and immediately post-exercise (t = 210 min), 40 min post-exercise (t = 250 min), 100 min post-exercise (t = 310 min) and 190 min post-exercise (t = 400 min)
Secondary outcome [1] 308888 0
Gut comfort measured using a custom design Likert scale questionnaire.
Timepoint [1] 308888 0
pre-trial (time = 0 min); pre-exercise (t = 115 min); and immediately post-exercise (t = 210 min)
Secondary outcome [2] 308889 0
Cycling time trial performance measured as the average work completed in the final 10 min of the cycling trial. Average work is measured using a Wattbike ergometer (Nottingham, UK) which estimates power using a load cell placed near the chain of the ergometer.
Timepoint [2] 308889 0
post-exercise (t = 210 min)

Eligibility
Key inclusion criteria
Aged 17 to 32 y; greater than or equal to 18 mo cycling racing experience; able to commit to a 10 d camp based at the Australian Institute in Canberra.
Minimum age
17 Years
Maximum age
32 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria were vitamin D deficiency (25-OH Vitamin D < 30 ng/mL), thyroid dysfunction (n=1), liver or kidney dysfunction, regular use of medications or supplements known to affect bone or calcium metabolism or thyroid function (e.g., thiazide diuretics, bisphosphonates, oral steroids).

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following approval from the Australian Institute of Sport Ethics Committee, emails advertising the study were circulated to all State Sport Institutes and Cycling Coaches, athletes previously involved in such studies and training camps and National Road Series team managers and athletes.

The Australian National Road Series had 107 female cyclists registered at the time of this study and an average (+/- SD) race attendance of 47 +/- 16. Of this population, 33 cyclists expressed interest in participating and 25 met the inclusion criteria (17 to 32 y; greater than or equal to 18 mo racing experience; no medical condition affecting calcium homeostasis, able to commit to 10 d camp). The additional participants included an international professional, an ultra-endurance mountain biker and 5 well-trained National club-level cyclists.

This was a counterbalanced crossover design meaning that subjects served as their own control. The order with which they received the experimental and control treatments was randomised.
Subjects were randomised into one of two groups that were balanced for menstrual phase (luteal or follicular which was confirmed with measures of oestrogen and progesterone on trial day one; ovulation was avoided), menstrual regularity (amenorrhea, oligomenorrhea or regular) and use of contraceptives (oral contraceptive pills, contraceptive devices, implants or injections).
Allocation concealment was not carried out. The same person who determined eligibility also determined group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group 1 received the control treatment meal first and group 2 received the treatment (calcium-rich) meal first. Subjects were sorted based on menstrual regularity (irregular or regular) and use of contraceptives. Subjects were then randomised into groups 1 and 2 using a computerised sequence generation (www.random.org) so that each group had an equal number of subjects who had a regular menstrual cycle and of those an equal number who were in their follicular or luteal phase; irregular menstrual cycle; or were using a contraceptive device.
This was deemed more appropriate than using a random number generator prior to accounting for menstrual status, as menstrual status is known to effect calcium homeostasis and so balancing the groups was prioritised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study was sized to detect a 20 pg/mL attenuation in the pre-post exercise difference in serum PTH due to the administration of calcium using a paired t test, assuming a SD of the difference of 30 pg/mL, with 95% power at the 0.05 level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
13/05/2013
Actual
13/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289435 0
Commercial sector/Industry
Name [1] 289435 0
Dairy Australia
Country [1] 289435 0
Australia
Primary sponsor type
Other
Name
Australian Institute of Sport - Nutrition, Physiology
Address
Leverrier Street, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 288125 0
None
Name [1] 288125 0
Address [1] 288125 0
Country [1] 288125 0
Other collaborator category [1] 278006 0
University
Name [1] 278006 0
Monash University
School of Public Health & Preventive Medicine
Department of Epidemiology & Preventive Medicine
Address [1] 278006 0
Level 6, The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
Country [1] 278006 0
Australia
Other collaborator category [2] 278007 0
University
Name [2] 278007 0
University of Queensland
School of Human Movement Studies
Address [2] 278007 0
The University of Queensland, Brisbane, QLD 4072
Country [2] 278007 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291193 0
Australian Institute of Sport Ethics Committee
Ethics committee address [1] 291193 0
Ethics committee country [1] 291193 0
Australia
Date submitted for ethics approval [1] 291193 0
09/04/2013
Approval date [1] 291193 0
01/05/2013
Ethics approval number [1] 291193 0
20130407

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 91 91 0 0
/AnzctrAttachments/366558-AIS Ethic Approval Haakonssen-20130407.pdf
Attachments [2] 92 92 0 0
/AnzctrAttachments/366558-Calcium Info sheet v2.pdf

Contacts
Principal investigator
Name 49290 0
Mr Eric Haakonssen
Address 49290 0
Australian Institute of Sport
Physiology
Leverrier Street, Bruce ACT 2617
Country 49290 0
Australia
Phone 49290 0
+61437013165
Fax 49290 0
Email 49290 0
[email protected]
Contact person for public queries
Name 49291 0
Eric Haakonssen
Address 49291 0
Australian Institute of Sport
Physiology
Leverrier Street, Bruce ACT 2617
Country 49291 0
Australia
Phone 49291 0
+61437013165
Fax 49291 0
Email 49291 0
[email protected]
Contact person for scientific queries
Name 49292 0
Eric Haakonssen
Address 49292 0
Australian Institute of Sport
Physiology
Leverrier Street, Bruce ACT 2617
Country 49292 0
Australia
Phone 49292 0
+61437013165
Fax 49292 0
Email 49292 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effects of a calcium-rich pre-exercise meal on biomarkers of calcium homeostasis in competitive female cyclists a randomised crossover trial.2015https://dx.doi.org/10.1371/journal.pone.0123302
N.B. These documents automatically identified may not have been verified by the study sponsor.