Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001284853
Ethics application status
Approved
Date submitted
22/01/2021
Date registered
23/09/2021
Date last updated
5/09/2022
Date data sharing statement initially provided
23/09/2021
Date results information initially provided
5/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low Energy Availability (LEA) Threshold in Male Athletes
Scientific title
Bone turnover measures and resting metabolic rate as early markers of low energy availability (LEA) in male athletes.
Secondary ID [1] 303246 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low energy availability 320427 0
Condition category
Condition code
Diet and Nutrition 318320 318320 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, counterbalanced crossover trial with three conditions - Adequate Energy Availability (AEA), Low energy availability (LEA) 2, and LEA1:
- AEA: 45 kcal/kgffm/day
- LEA2: 30 kcal/kgffm/day
- LEA1: 15 kcal/kgffm/day
Each participant will undertake each condition over 5 days with a washout period of 7-10 days between arms. On days 1 to 4 of each condition, energy intake will be controlled through diet by providing foods that will include microwavable frozen meals, biscuits, nuts, protein powder, etc. The food will consist of 50% carbohydrates, 20% protein, 30% fats. The researchers will monitor the participants adherence to the intervention by participant self-report diary and through constant communication via text messages daily. In addition, each participant will undertake exercise equivalent to 15 kcal/kgffm/day. Each day’s exercise session will be treadmill running at 65% of maximum oxygen uptake, duration approximately 90 minutes (15 minutes run, 5 minutes break, 6 sets in total). All exercise sessions will be supervised by the researchers. Energy availability will be calculated as energy intake minus energy expenditure through exercise.

All physical testing (metabolic measures, blood sampling, exercise) will take place in a controlled laboratory environment at the Nanyang Technological University National Institute of Education. The participants will be asked to bring home each day’s food and will have to finish the food by 10pm (on the same day).
Intervention code [1] 319551 0
Prevention
Intervention code [2] 321038 0
Lifestyle
Comparator / control treatment
The comparator group is the adequate energy intake group (45 kcal/kgffm/day).
Control group
Dose comparison

Outcomes
Primary outcome [1] 326290 0
Change in resting metabolic rate (RMR) measured via indirect calorimetry (ventilated hood dilution method)
Timepoint [1] 326290 0
RMR will be measured on Day 1 and Day 5 of each trial condition.
Primary outcome [2] 326291 0
Change in bone resorption marker ß-CTX (ß-carboxyterminal cross-linked telopeptide of type I collagen), bone formation marker P1NP (propeptide of type I procollagen) and osteocalcin (Oc), assessed using blood samples. A 10ml sample of venous blood will be taken from an antecubital vein, and dispensed into a silicon-coated vacutainer tube, ethylenediaminetetraacetic acid (EDTA) tube, The sample will be centrifuged at 3500rpm, 20 degree celcius,for 11 minutes. The plasma will be pipetted off and frozen at -86?Celsius for subsequent analyses.
Timepoint [2] 326291 0
Blood samples will be drawn on Day 1 and Day 5 of each trial condition.
Secondary outcome [1] 390925 0
Change in body mass will be measured with Inbody 720, InBody, South Korea.
Timepoint [1] 390925 0
Body mass will be measured on Day 1 and Day 5 of each trial condition.
Secondary outcome [2] 390926 0
Change in body fat percentage will be measured with Inbody 720, InBody, South Korea.
Timepoint [2] 390926 0
Body fat percentage will be measured on Day 1 and Day 5 of each trial condition.
Secondary outcome [3] 390927 0
Change in mood score measured by the Brunel Mood Scale
Timepoint [3] 390927 0
Mood score will be measured on Day 1 and Day 5 of each trial condition.

Eligibility
Key inclusion criteria
1) Male
2) Age: 21-35 years
3) Complete at least 3 running sessions/week on a regularly basis
4) Running at least 24km a week on a regular basis
5) Self-reported weight stable (±3 kg) in the past three months and not actively trying to lose weight by self-report
6) Body mass index: 19-25 kg·m-2
7) Normal blood pressure (less than 120/80 mmHg and greater than 90/60 mmHg)
8) Normal blood glucose level (less than 6.0 mmol/ L and greater than 3.9 mmol/L)
9) Healthy, injury-free (e.g. no cardiovascular disease, diabetes mellitus, orthopaedic impairment that interferes with moderate-to-vigorous exercise)
10) No previous or current diagnosis of eating disorder(s)/No known or deliberate disordered eating behaviours
11) No special diets (e.g. vegan, vegetarian, ketogenic diet)
- Halal dietary requirements is acceptable
12) Non-smoker
Minimum age
21 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any diagnosed form of cardiometabolic disease (cardiovascular disease, diabetes, metabolic syndrome, hypertension)
2) Any symptoms contraindication of exercise testing (eg chest pains)
3) Any balance or dizziness problems
4) Any chronic medical conditions (whether medicated or not)
5) Any bone joint problems
6) Any Physician diagnosed contraindications to exercise
7) If you drink alcohol more than 3 times each week and more than 3 drinks each time
8) Tick Yes to any questions in Part 1 of the Physical Activity Readiness Questionnaire Plus.
9) Any allergies to food items used in the prescribed meals.
10) A score on the Sick, Control, One, Fat, Food (SCOFF) questionnaire of 2 or more.
11) A score on the Exercise Addiction Inventory of 24 or more.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
12 male participants will be recruited. An a priori sample size analysis to detect a large effect size (Cohen’s f) of 1.0 was calculated using G*Power v3.1 (Universität Kiel, Kiel, Germany). For one group undergoing three conditions in a repeated measures design with an alpha level of 0.05, 12 participants will provide 83.2% power to detect differences among conditions.

All data will be checked for normality using the Shapiro-Wilk test. Non-normally distributed data will be transformed prior to interpretation. Mean and Standard Deviation (SD) will be used to represent all continuous data collected, including anthropometric data. A one-way repeated measures ANOVA will be used to determine the difference in the changes in primary and secondary outcomes across arms. Two-way repeated measures ANOVA will be used to determine the difference among arms over time (Day 1 (pre-test) to Day 5 (post-test)) for all outcomes. Post-hoc Bonferroni comparison test will be used to identify the differences between the conditions. Significance will be set as p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
30/08/2021
Date of last data collection
Anticipated
5/07/2022
Actual
1/10/2021
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 23402 0
Singapore
State/province [1] 23402 0

Funding & Sponsors
Funding source category [1] 307656 0
University
Name [1] 307656 0
National Institute of Education, Nanyang Technological University
Country [1] 307656 0
Singapore
Primary sponsor type
University
Name
National Institute of Education, Nanyang Technological University
Address
1 Nanyang Walk, Singapore 637616
Country
Singapore
Secondary sponsor category [1] 308349 0
None
Name [1] 308349 0
Address [1] 308349 0
Country [1] 308349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307694 0
Nanyang Technological University Institutional Review Board
Ethics committee address [1] 307694 0
NTU-Institutional Review Board
Research Integrity and Ethics Office
Blk N1.2, B1-02A
62 Nanyang Drive
Singapore 637459
Ethics committee country [1] 307694 0
Singapore
Date submitted for ethics approval [1] 307694 0
10/03/2020
Approval date [1] 307694 0
06/08/2020
Ethics approval number [1] 307694 0
IRB-2020-03-040

Summary
Brief summary
12 male volunteers (aged 21 to 35 years) will complete a randomised crossover trial with with three conditions - Adequate Energy Availability (AEA), Low energy availability (LEA) 2, and LEA1:

- AEA: 45 kcal/kgffm/day
- LEA2: 30 kcal/kgffm/day
- LEA1: 15 kcal/kgffm/day

Each participant will undertake each condition over 5 days with a washout period of 7-10 days between arms. On days 1 to 4, energy availability of the participants will be controlled via fixed energy intake and exercise energy expenditure. Pre and post measurements will be done on Day 1 and Day 5 of each condition,

The study hypothesizes that change in RMR, bone turnover markers, and mood states will occur at an energy availability of 15 kcal/kgffm/day.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108170 0
A/Prof Stephen Francis Burns
Address 108170 0
Physical Education and Sports Science
NIE5-03-32A, National Institute of Education
1 Nanyang Walk
Nanyang Technological University
Singapore 637616
Country 108170 0
Singapore
Phone 108170 0
+65 62196214
Fax 108170 0
Email 108170 0
[email protected]
Contact person for public queries
Name 108171 0
A/Prof Stephen Francis Burns
Address 108171 0
Physical Education and Sports Science
NIE5-03-32A, National Institute of Education
1 Nanyang Walk
Nanyang Technological University
Singapore 637616
Country 108171 0
Singapore
Phone 108171 0
+65 62196214
Fax 108171 0
Email 108171 0
[email protected]
Contact person for scientific queries
Name 108172 0
A/Prof Stephen Francis Burns
Address 108172 0
Physical Education and Sports Science
NIE5-03-32A, National Institute of Education
1 Nanyang Walk
Nanyang Technological University
Singapore 637616
Country 108172 0
Singapore
Phone 108172 0
+65 62196214
Fax 108172 0
Email 108172 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results.
When will data be available (start and end dates)?
Beginning immediately after main results publication and made available for 10 years.
Available to whom?
Upon reasonable request on a case-by-case basis to the Principal Investigator.
Available for what types of analyses?
Meta-analyses in the area of the primary and secondary study outcomes.
How or where can data be obtained?
Data related to any publication will be placed in the National Institute of Education Data Repository for 10 years after the publication date and will be made available on a case-by-case basis upon reasonable request to the Principal Investigator (email: [email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10324Ethical approval  [email protected] 381278-(Uploaded-05-07-2021-18-30-58)-Study-related document.pdf
10325Informed consent form  [email protected] 381278-(Uploaded-05-07-2021-18-31-16)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.