Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001015134
Ethics application status
Approved
Date submitted
28/06/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Date results provided
15/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dietary periodisation to support training outcomes in elite distance athletes (Supernova 1)
Scientific title
Dietary periodisation to support training outcomes in elite distance athletes
Secondary ID [1] 298627 0
nil
Universal Trial Number (UTN)
U1111-1236-1410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Athlete nutrition 313498 0
Athlete performance 313547 0
Condition category
Condition code
Diet and Nutrition 311919 311919 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 311920 311920 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 311921 311921 0 0
Normal musculoskeletal and cartilage development and function
Inflammatory and Immune System 311923 311923 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study is to investigate the effects 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: 1) control (described separately); 2) LCHF or 3) 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. Training will include weekly hill sessions, reps sessions at the track, long walks of 20-45km, and self-selected training sessions based on individual training plans.
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.
Expected training volume per week will be between 120 and 150 km.
Intervention code [1] 314890 0
Treatment: Other
Comparator / control treatment
High carbohydrate (CHO) availability for all training sessions: daily targets 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] 320589 0
Performance in the 25 km walk test
Assessed via time to complete the test (stopwatches)
Timepoint [1] 320589 0
1 day testing block, imediately Pre- and post 3-week training block
Primary outcome [2] 320590 0
Substrate utilisation; CHO and fat oxidation measured via respiratory gas exchange data;
This is a composite outcome.
Timepoint [2] 320590 0
At 0 , 10 and 20 km of standardised 25km test undertaken after 3 w intervention under conditions of treatment
Primary outcome [3] 320591 0
Performance in the 10km race walk race;
Assessed via time to complete the test (stopwatches and official race time)
Timepoint [3] 320591 0
Race will be completed immediately Pre- and post 3w training block
Secondary outcome [1] 372123 0
Daily training;
Athletes will be required to fill out daily training logs on AMS (Athlete Management System) noting sessions completed and RPE
Timepoint [1] 372123 0
Throughout 3 week training block, daily.
Secondary outcome [2] 372125 0
Body composition; DXA measurement of whole body composition, fat free mass, fat mass and whole body and site specific (femur, spine) bone mineral density;
this is a composite outcome
Timepoint [2] 372125 0
Immediately Pre- and post 3w training block
Secondary outcome [3] 372126 0
Insulin sensitivity; Quasi OGTT test done as post-prandial response to CHO-rich breakfast; this is called a quasi OGTT as the CHO dose is specific to body mass (2 g/kg) and as the source is a meal (toast and jam and juice) instead of pure glucose.
Timepoint [3] 372126 0
Response to CHO rich breakfast consumed prior to standardised training bout undertaken immediately before and after 3w training block (same testing day as the 25km test)
Secondary outcome [4] 372127 0
Lipid status; Cholesterol (total and sub-fractions), triglycerides via venous blood samples;
this is a composite measure
Timepoint [4] 372127 0
Immediately pre- and post 3w training block; on the same day as the 25km test
Secondary outcome [5] 372128 0
illness logs via AMS
Timepoint [5] 372128 0
The presence or absence of illness will be assessed daily throughout 3 week training block
Secondary outcome [6] 372129 0
Blood immune markers (interleukin-6) and saliva immune markers (Ig-A); a composite measure; assessed via venous blood samples
Timepoint [6] 372129 0
Immediately before and 3 h post standardised 25 km training bout undertaken at beginning and end of 3w training block
Secondary outcome [7] 372130 0
Chronic inflammation, soreness, injuries; this is a composite measure as it refers to the presence of injury / overuse symptoms in athletes; this will be assessed as presence or absence of symptoms with the use of AMS with specific questions on these symptoms
Timepoint [7] 372130 0
assessed daily throughout 3 week training block
Secondary outcome [8] 372131 0
Blood markers of inflammation; C-reactive protein, cytokines (IL-6, TNF-alpha);
this is a composite measure; assessed via venous blood samples
Timepoint [8] 372131 0
Immediately before and 3 h post standardised training undertaken at beginning and end of 3w training block
Secondary outcome [9] 372132 0
Iron status; Hb, ferritin, transferrin saturation, sTfR; this is a composite measure; assessed via venous blood samples
Timepoint [9] 372132 0
Immediately pre- and post 3w training block, measured in a resting state
Secondary outcome [10] 372133 0
Hepcidin response to training session (Hepcidin and Il-6); composite measure; assessed via venous blood samples
Timepoint [10] 372133 0
Immediately pre and 3 h post standardised 25km training bout undertaken at beginning and end of training block
Secondary outcome [11] 372134 0
Microbiome; Gut flora from fecal samples; this is a composite outcome
Timepoint [11] 372134 0
Immediately pre- and post 3w training block (single fecal sample at each time point)
Secondary outcome [12] 372135 0
Oral microbiome from mouth swab
Timepoint [12] 372135 0
immediately before the 3 w training block (in comparison to normal population)
Secondary outcome [13] 372136 0
Bone metabolism (CTX, OC, PINP); composite outcome; assessed via venous blood samples and analysed via ELISA
Timepoint [13] 372136 0
At 2 and 0 h before and 0 and 3 h after a 25km standardised walking test; completed before and after 3 w training block.
Secondary outcome [14] 372241 0
Daily life quality;
Athletes will be required to fill out daily DALDA questionnaire
Timepoint [14] 372241 0
Daily throughout the 3 w training block
Secondary outcome [15] 372242 0
Daily life quality;
Athletes will be required to wear sleep monitors to monitor sleep quality
Timepoint [15] 372242 0
Daily throughout the 3 w block
Secondary outcome [16] 372243 0
Training outcomes at weekly reps and hill session; fingerprick lactate, glucose and ketone measures via portable monitors, RPE; HR via HR monitors; composite outcome
Timepoint [16] 372243 0
Twice a week throughout the 3 w block

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
o all competitive Australian male race walkers and
o 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)
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
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)
na
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
• Calculations have determined that a minimum of 8 subjects with full data completion is required for sufficient power in most areas of interest. In view of the chronic nature of the study and capacity for injuries or other issues unrelated to the study intervention to occur, we have therefore increased recruitment to 12 subjects per treatment group with the capacity to allow for dropouts or incomplete data collection for some variables

Statistical analysis will be done with linear mixed models to account for multiple camp experiences and differences in participants characteristics between treatment groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
1/11/2015
Date of last data collection
Anticipated
Actual
21/02/2016
Sample size
Target
36
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21651 0
New Zealand
State/province [1] 21651 0
Country [2] 21652 0
Canada
State/province [2] 21652 0
Country [3] 21653 0
Chile
State/province [3] 21653 0
Country [4] 21654 0
Japan
State/province [4] 21654 0
Country [5] 21655 0
Sweden
State/province [5] 21655 0
Country [6] 21656 0
Poland
State/province [6] 21656 0
Country [7] 21657 0
South Africa
State/province [7] 21657 0
Country [8] 21658 0
Lithuania
State/province [8] 21658 0

Funding & Sponsors
Funding source category [1] 303168 0
University
Name [1] 303168 0
Australian Catholic University
Country [1] 303168 0
Australia
Funding source category [2] 303169 0
Government body
Name [2] 303169 0
Australian Institute of Sport
Country [2] 303169 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 303173 0
Government body
Name [1] 303173 0
Australian Institute of Sport
Address [1] 303173 0
Leverrier St, 2617 Bruce, ACT
Country [1] 303173 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303729 0
AIS ETHICS COMMITTEE
Ethics committee address [1] 303729 0
Ethics committee country [1] 303729 0
Australia
Date submitted for ethics approval [1] 303729 0
20/07/2015
Approval date [1] 303729 0
17/08/2015
Ethics approval number [1] 303729 0
20150802

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

Contacts
Principal investigator
Name 94598 0
Prof Louise Burke
Address 94598 0
Australian Institute of Sport
Leverrier St, 2617 Bruce, ACT
Country 94598 0
Australia
Phone 94598 0
+61 2 62141351
Fax 94598 0
Email 94598 0
[email protected]
Contact person for public queries
Name 94599 0
Louise Burke
Address 94599 0
Australian Institute of Sport
Leverrier St, 2617 Bruce, ACT
Country 94599 0
Australia
Phone 94599 0
+61 2 62141351
Fax 94599 0
Email 94599 0
[email protected]
Contact person for scientific queries
Name 94600 0
Louise Burke
Address 94600 0
Australian Institute of Sport
Leverrier St, 2617 Bruce, ACT
Country 94600 0
Australia
Phone 94600 0
+61 2 62141351
Fax 94600 0
Email 94600 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 and published, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by 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
No additional documents have been identified.