Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000794101
Ethics application status
Approved
Date submitted
20/05/2019
Date registered
29/05/2019
Date last updated
29/05/2019
Date data sharing statement initially provided
29/05/2019
Date results provided
29/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supernova 2: Dietary periodisation and de-adaptation to support training outcomes in elite race walkers
Scientific title
Supernova 2: Dietary periodisation and de-adaptation to support training outcomes in elite race walkers
Secondary ID [1] 298285 0
none
Universal Trial Number (UTN)
U1111-1233-7454
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise metabolism 312905 0
Inflammation 312906 0
Bone health 312907 0
Gut health 312908 0
Condition category
Condition code
Diet and Nutrition 311395 311395 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 311396 311396 0 0
Normal development and function of the immune system
Metabolic and Endocrine 311397 311397 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 311398 311398 0 0
Normal musculoskeletal and cartilage development and function
Oral and Gastrointestinal 311399 311399 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of Supernova 2 is to investigate the effects of de-adaptation following 3 weeks of adaptation to the low carbohydrate high fat (LCHF diet), on substrate use and subsequent race performance in elite female and male race walkers.
Intervention diets will be control (described separately) and LCHF and periodised CHO diets (described below):
High-fat low carbohydrate diet (LCHF) : 70-80% fat, 15-25% protein, <50g/d CHO: recently re-emerged dietary strategy to promote increased ability for fat utilisation as a muscle fuel and promoted by Professor Tim Noakes as “the future of endurance performance”
Periodised diet involving a careful integration of sessions with high CHO availability (high muscle glycogen, CHO feeding during session), low CHO availability (low pre-exercise glycogen or overnight fasted or delayed refuelling) and well-timed protein intake. With target energy intake isocaloric to LCHF but as follows: CHO 8.5 g/kg body mass, protein 2.1 g/kg body mass, fat 1.2 g/kg body mass.
Interventions will last 3 weeks and dietary treatments will commence on the first day of intervention and last until the end.
The diets will be designed by researchers and sports dietitians and all food will be provided for the participants in an individualised fashion (i.e. based on each participant's body weight). Check lists will be available at main meals where a member of the research team will supervise compliance and check that all daily snacks for that day have been consumed.
No food or drinks (other than water) will be consumed outside of individual meal plans. Non-energy drinks including black coffee, tea and carbonated water or diet soda can be consumed ad libitum but will require reporting.
Subject allocation into dietary treatments will be done based on preference as belief effect is important in exercise nutrition research.
Intervention code [1] 314522 0
Treatment: Other
Comparator / control treatment
Control treatment will be the High carbohydrate availability (HCHO) diet, where high CHO intake is provided for all training sessions [= 1990s sports nutrition guidelines]: ~ 65% carbohydrate, 15% protein, 20% fat; or CHO 8.5 g/kg body mass, protein 2.1 g/kg body mass, fat 1.2 g/kg body mass.
Control group
Active

Outcomes
Primary outcome [1] 320119 0
Substrate (carbohydrate and fat) utilisation during graded exercise test (fasted)
This will be measured from respiratory gas exchange data at different exercise intensities.
Timepoint [1] 320119 0
Pre-intervention, 3 weeks post-intervention commencement and 2 weeks post intervention-completion,
Primary outcome [2] 320120 0
Whole body substrate utilisation during CHO-fed long walk
This will be measured from respiratory gas exchange data. as well as utilising a 14C glucose tracer added to the sports drink during exercise to quantify exogenous CHO oxidation;
As well as from fingertip blood glucose, lactate and ketone samples during the tests
Timepoint [2] 320120 0
Pre-intervention, 3 weeks post-intervention commencement and 2 weeks post intervention-completion,
Substrate utilisation At 0 , 6, 12, 18 and 24 km of long walk
Primary outcome [3] 320121 0
Response of bone markers (CTX, PINP, Glu-OC, OC) to training session
Assessed via venous blood sample collection during standardised long walk protocol
Bone metabolism is a composite marker that includes formation (PINP, OC, Glu-OC) and resorption (CTX)
Timepoint [3] 320121 0
Pre-intervention, 3 weeks post-intervention commencement and 2 weeks post intervention-completion,
Pre and 3 h post 25km Long Walks
Secondary outcome [1] 370578 0
Bone mineral density - composite outcome
Timepoint [1] 370578 0
Baseline measure of hip and femur BMD via DXA scans
Secondary outcome [2] 370579 0
Iron measures (Hb, ferritin, sTfR, transferrin) via venous blood samples
This is a composite outcome of iron status
Timepoint [2] 370579 0
Pre- and post 3 w dietary periodisation intervention
Secondary outcome [3] 370580 0
Inflammatory (IL6, hepcidin) response to training session via venous blood samples
This is a composite outcome of inflammation
Timepoint [3] 370580 0
Pre and 3 h post Long Walks at pre- and post 3 w dietary periodisation intervention
Secondary outcome [4] 370581 0
Chronic inflammation (CRP, IL6, TNFa) via venous blood samples
This is a composite outcome
Timepoint [4] 370581 0
Pre and 3 h post Long Walks - pre- and post 3 w dietary periodisation intervention
Secondary outcome [5] 370582 0
Illness logs (google docs)
Timepoint [5] 370582 0
Throughout 6 week traning block
Secondary outcome [6] 370583 0
Blood Lipid profile (cholesterol, triglycerides) via venous blood samples
This is a composite outcome
Timepoint [6] 370583 0
Pre- and post 3 w dietary periodisation intervention
Secondary outcome [7] 370584 0
Insulin sensitivity;
Quasi OGTT test done as post-prandial response to CHO-rich breakfast;
Venous blood samples: glucose and insulin
This is a composite outcome
Timepoint [7] 370584 0
Pre-intervention, 3 weeks post-intervention commencement and 2 weeks post intervention-completion,
Secondary outcome [8] 370585 0
Resting metabolic rate via first principles douglas bags collection method and hormone health (testosterone, IGF1, T3) via venous blood samples
Composite variable looking at metabolic function in response to intervention
Timepoint [8] 370585 0
Measurement of RMR and hormones in Fasted, rested conditions;
Pre- and post 3 w dietary periodisation intervention
Secondary outcome [9] 370586 0
Body composition (via DXA): lean mass, fat mass
Composite outcome looking at changes in body composition
Timepoint [9] 370586 0
Pre- and post 3 w dietary periodisation intervention
Secondary outcome [10] 370587 0
Race walk performance (lab);
Walking economy test
A time to exhaustion (time it takes to complete the last step - measured via stopwatch) will be completed at the last step to measure VO2max
Timepoint [10] 370587 0
Pre- and post 3 w dietary periodisation intervention
Secondary outcome [11] 370588 0
Field race walk test (10,000m race)
Time to complete (stopwatches and official time from the race will be used) will be the main outcome
Timepoint [11] 370588 0
Pre- and post 3 w dietary periodisation intervention
Secondary outcome [12] 370589 0
20 km race
Time to complete will be the main outcome (official race time recorded by race officials will be used)
Timepoint [12] 370589 0
National championships (Adelaide) – Feb 19
Post study test
Secondary outcome [13] 370590 0
Daily training capacity;
Athletes will be required to fill out daily training logs on Google Docs noting sessions completed, RPE and outcomes (distance, time)
This is a composite outcome
Timepoint [13] 370590 0
Throughout 6 week training block
Secondary outcome [14] 370591 0
Training capacity;
Training outcomes (HR, RPE, time to complete training session/repetitions, blood ketones, glucose and lactate pre and post sessions) at interval and hill session
All outcomes are researcher-captured metrics
Blood ketones, glucose and lactate will be assessed using portable monitors. HR will be assessed using heart rate monitors. RPE will be assessed on a scale from 6 to 20 (Borg scale)
This is a composite outcome
Timepoint [14] 370591 0
2 sessions per week throughout 6 week training block
Secondary outcome [15] 370592 0
Mental function (stroop color test)
Timepoint [15] 370592 0
Weekly for 6 weeks: Pre/post hill session
Secondary outcome [16] 370713 0
Daily training and life quality;
DALDA
Timepoint [16] 370713 0
Daily for 6 weeks

Eligibility
Key inclusion criteria
IAAF qualifying standard for Race Walking for World Championships/Olympic Games and able to fulfil the training program and dietary interventions

Participation will be open to
• all competitive Australian female and male race walkers and
• international race walkers by invitation from Athletics Australia (whereby walkers are deemed to be able to contribute to the required training environment and study goals without interfering with AWE targets by gaining an advantage over Australian athletes). Females will be chosen to balance the involvement of 1-2 key Australian female athletes
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to fulfil the training program and dietary interventions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Metabolic and Performance data from Supernova 1 justifies the target of 8 subjects in each group (10 to commence to allow for injuries or other reasons for inability to undertake all testing). Some unreported data collected in Supernova 1 may be added to Supernova 2 to increase samples sizes ( e.g. RMR data) while knowledge gained in Supernova 1 has identified baseline issues that need to be standardised (e.g. iron status) to reduce variability of some test variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/01/2017
Date of last participant enrolment
Anticipated
Actual
5/01/2017
Date of last data collection
Anticipated
Actual
19/02/2017
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21498 0
New Zealand
State/province [1] 21498 0
Country [2] 21499 0
Canada
State/province [2] 21499 0
Country [3] 21500 0
Chile
State/province [3] 21500 0
Country [4] 21501 0
Italy
State/province [4] 21501 0
Country [5] 21502 0
Japan
State/province [5] 21502 0
Country [6] 21503 0
Poland
State/province [6] 21503 0
Country [7] 21504 0
Finland
State/province [7] 21504 0
Country [8] 21505 0
United Kingdom
State/province [8] 21505 0
Country [9] 21506 0
South Africa
State/province [9] 21506 0
Country [10] 21507 0
Lithuania
State/province [10] 21507 0
Country [11] 21508 0
Hungary
State/province [11] 21508 0
Country [12] 21509 0
Spain
State/province [12] 21509 0
Country [13] 21510 0
United States of America
State/province [13] 21510 0

Funding & Sponsors
Funding source category [1] 302826 0
University
Name [1] 302826 0
Australian Catholic University
Country [1] 302826 0
Australia
Funding source category [2] 302827 0
Government body
Name [2] 302827 0
Australian Institute of Sport
Country [2] 302827 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 302775 0
None
Name [1] 302775 0
Address [1] 302775 0
Country [1] 302775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303408 0
AIS ETHICS COMMITTEE
Ethics committee address [1] 303408 0
Ethics committee country [1] 303408 0
Australia
Date submitted for ethics approval [1] 303408 0
14/11/2016
Approval date [1] 303408 0
12/12/2016
Ethics approval number [1] 303408 0
20161201

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93574 0
Prof Louise Burke
Address 93574 0
Australian Institute of Sport
Leverrier St
2617 Bruce, ACT
Country 93574 0
Australia
Phone 93574 0
+61 422 635 869
Fax 93574 0
Email 93574 0
[email protected]
Contact person for public queries
Name 93575 0
Louise Burke
Address 93575 0
Australian Institute of Sport
Leverrier St
2617 Bruce, ACT
Country 93575 0
Australia
Phone 93575 0
+61 422 635 869
Fax 93575 0
Email 93575 0
[email protected]
Contact person for scientific queries
Name 93576 0
Louise Burke
Address 93576 0
Australian Institute of Sport
Leverrier St
2617 Bruce, ACT
Country 93576 0
Australia
Phone 93576 0
+61 422 635 869
Fax 93576 0
Email 93576 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?
all of the individual participant data collected during the trial, underlying published results after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
Online journal: main paper will be published as open access in PLOS One.
Other papers from this investigation will be published across several peer reviewed journals depending on the focus of each paper. If these journals do not provide open access options, the papers will be available by emailing the principal investigator ([email protected]).


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
EmbaseCrisis of confidence averted: Impairment of exercise economy and performance in elite race walkers by ketogenic low carbohydrate, high fat (LCHF) diet is reproducible.2020https://dx.doi.org/10.1371/journal.pone.0234027
N.B. These documents automatically identified may not have been verified by the study sponsor.