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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)
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Scientific title
Dietary periodisation to support training outcomes in elite distance athletes
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Secondary ID [1]
298627
0
nil
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Universal Trial Number (UTN)
U1111-1236-1410
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Athlete nutrition
313498
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Athlete performance
313547
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Condition category
Condition code
Diet and Nutrition
311919
311919
0
0
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Other diet and nutrition disorders
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Metabolic and Endocrine
311920
311920
0
0
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Normal metabolism and endocrine development and function
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Musculoskeletal
311921
311921
0
0
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Normal musculoskeletal and cartilage development and function
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Inflammatory and Immune System
311923
311923
0
0
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Normal development and function of the immune system
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314890
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Performance in the 25 km walk test
Assessed via time to complete the test (stopwatches)
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Assessment method [1]
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Timepoint [1]
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1 day testing block, imediately Pre- and post 3-week training block
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Primary outcome [2]
320590
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Substrate utilisation; CHO and fat oxidation measured via respiratory gas exchange data;
This is a composite outcome.
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Assessment method [2]
320590
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Timepoint [2]
320590
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At 0 , 10 and 20 km of standardised 25km test undertaken after 3 w intervention under conditions of treatment
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Primary outcome [3]
320591
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Performance in the 10km race walk race;
Assessed via time to complete the test (stopwatches and official race time)
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Assessment method [3]
320591
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Timepoint [3]
320591
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Race will be completed immediately Pre- and post 3w training block
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Secondary outcome [1]
372123
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Daily training;
Athletes will be required to fill out daily training logs on AMS (Athlete Management System) noting sessions completed and RPE
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Assessment method [1]
372123
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Timepoint [1]
372123
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Throughout 3 week training block, daily.
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Secondary outcome [2]
372125
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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
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Assessment method [2]
372125
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Timepoint [2]
372125
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Immediately Pre- and post 3w training block
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Secondary outcome [3]
372126
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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.
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Assessment method [3]
372126
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Timepoint [3]
372126
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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)
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Secondary outcome [4]
372127
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Lipid status; Cholesterol (total and sub-fractions), triglycerides via venous blood samples;
this is a composite measure
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Assessment method [4]
372127
0
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Timepoint [4]
372127
0
Immediately pre- and post 3w training block; on the same day as the 25km test
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Secondary outcome [5]
372128
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illness logs via AMS
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Assessment method [5]
372128
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Timepoint [5]
372128
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The presence or absence of illness will be assessed daily throughout 3 week training block
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Secondary outcome [6]
372129
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Blood immune markers (interleukin-6) and saliva immune markers (Ig-A); a composite measure; assessed via venous blood samples
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Assessment method [6]
372129
0
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Timepoint [6]
372129
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Immediately before and 3 h post standardised 25 km training bout undertaken at beginning and end of 3w training block
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Secondary outcome [7]
372130
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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
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Assessment method [7]
372130
0
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Timepoint [7]
372130
0
assessed daily throughout 3 week training block
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Secondary outcome [8]
372131
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Blood markers of inflammation; C-reactive protein, cytokines (IL-6, TNF-alpha);
this is a composite measure; assessed via venous blood samples
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Assessment method [8]
372131
0
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Timepoint [8]
372131
0
Immediately before and 3 h post standardised training undertaken at beginning and end of 3w training block
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Secondary outcome [9]
372132
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Iron status; Hb, ferritin, transferrin saturation, sTfR; this is a composite measure; assessed via venous blood samples
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Assessment method [9]
372132
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Timepoint [9]
372132
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Immediately pre- and post 3w training block, measured in a resting state
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Secondary outcome [10]
372133
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Hepcidin response to training session (Hepcidin and Il-6); composite measure; assessed via venous blood samples
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Assessment method [10]
372133
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Timepoint [10]
372133
0
Immediately pre and 3 h post standardised 25km training bout undertaken at beginning and end of training block
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Secondary outcome [11]
372134
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Microbiome; Gut flora from fecal samples; this is a composite outcome
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Assessment method [11]
372134
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Timepoint [11]
372134
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Immediately pre- and post 3w training block (single fecal sample at each time point)
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Secondary outcome [12]
372135
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Oral microbiome from mouth swab
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Assessment method [12]
372135
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Timepoint [12]
372135
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immediately before the 3 w training block (in comparison to normal population)
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Secondary outcome [13]
372136
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Bone metabolism (CTX, OC, PINP); composite outcome; assessed via venous blood samples and analysed via ELISA
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Assessment method [13]
372136
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Timepoint [13]
372136
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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.
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Secondary outcome [14]
372241
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Daily life quality;
Athletes will be required to fill out daily DALDA questionnaire
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Assessment method [14]
372241
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Timepoint [14]
372241
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Daily throughout the 3 w training block
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Secondary outcome [15]
372242
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Daily life quality;
Athletes will be required to wear sleep monitors to monitor sleep quality
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Assessment method [15]
372242
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Timepoint [15]
372242
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Daily throughout the 3 w block
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Secondary outcome [16]
372243
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Training outcomes at weekly reps and hill session; fingerprick lactate, glucose and ketone measures via portable monitors, RPE; HR via HR monitors; composite outcome
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Assessment method [16]
372243
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Timepoint [16]
372243
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Twice a week throughout the 3 w block
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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)
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Unable to fulfil the training program and dietary interventions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
na
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/11/2015
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Date of last participant enrolment
Anticipated
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Actual
1/11/2015
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Date of last data collection
Anticipated
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Actual
21/02/2016
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Sample size
Target
36
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Accrual to date
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Final
29
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
21651
0
New Zealand
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State/province [1]
21651
0
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Country [2]
21652
0
Canada
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State/province [2]
21652
0
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Country [3]
21653
0
Chile
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State/province [3]
21653
0
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Country [4]
21654
0
Japan
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State/province [4]
21654
0
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Country [5]
21655
0
Sweden
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State/province [5]
21655
0
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Country [6]
21656
0
Poland
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State/province [6]
21656
0
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Country [7]
21657
0
South Africa
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State/province [7]
21657
0
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Country [8]
21658
0
Lithuania
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State/province [8]
21658
0
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Funding & Sponsors
Funding source category [1]
303168
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University
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Name [1]
303168
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Australian Catholic University
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Address [1]
303168
0
115 Victoria Parade, Fitzroy VIC 3065
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Country [1]
303168
0
Australia
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Funding source category [2]
303169
0
Government body
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Name [2]
303169
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Australian Institute of Sport
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Address [2]
303169
0
Leverrier St, 2617 Bruce, ACT
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Country [2]
303169
0
Australia
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Primary sponsor type
University
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Name
Australian Catholic University
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Address
115 Victoria Parade, Fitzroy VIC 3065
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Country
Australia
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Secondary sponsor category [1]
303173
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Government body
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Name [1]
303173
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Australian Institute of Sport
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Address [1]
303173
0
Leverrier St, 2617 Bruce, ACT
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Country [1]
303173
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303729
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AIS ETHICS COMMITTEE
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Ethics committee address [1]
303729
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Leverrier Street, 2617 Bruce, ACT
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Ethics committee country [1]
303729
0
Australia
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Date submitted for ethics approval [1]
303729
0
20/07/2015
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Approval date [1]
303729
0
17/08/2015
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Ethics approval number [1]
303729
0
20150802
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Summary
Brief summary
There is controversy both in lay and scientific circles regarding the best dietary approach to promote maximum performance gains during training for endurance sports. The current study will utilise the recognised research skills of AIS Sports Nutrition and the AIS Canberra Campus environment to implement careful dietary control to compare the results of the three different dietary approaches to the same intensive and periodised training program in elite distance athletes: 1. High carbohydrate (CHO) availability for all training sessions 2. High-fat low CHO (LCHF) 3. Periodised diet involving a careful integration of sessions with high and low CHO availability We will examine the effect of a 3 week training block with these different approaches to dietary support on indices of health, adaptation of the metabolic response to exercise and performance in a cohort of highly competitive race walkers, undertaken within 2 training/research camps.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
94598
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Prof Louise Burke
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Address
94598
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Australian Institute of Sport
Leverrier St, 2617 Bruce, ACT
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Country
94598
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Australia
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Phone
94598
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+61 2 62141351
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Fax
94598
0
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Email
94598
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louise.burke@ausport.gov.au
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Contact person for public queries
Name
94599
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Louise Burke
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Address
94599
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Australian Institute of Sport
Leverrier St, 2617 Bruce, ACT
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Country
94599
0
Australia
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Phone
94599
0
+61 2 62141351
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Fax
94599
0
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Email
94599
0
louise.burke@ausport.gov.au
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Contact person for scientific queries
Name
94600
0
Louise Burke
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Address
94600
0
Australian Institute of Sport
Leverrier St, 2617 Bruce, ACT
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Country
94600
0
Australia
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Phone
94600
0
+61 2 62141351
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Fax
94600
0
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Email
94600
0
louise.burke@ausport.gov.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all of the individual participant data collected during the trial and published, after de-identification
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
anyone who wishes to access it
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Available for what types of analyses?
any purpose
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How or where can data be obtained?
access subject to approvals by Principal Investigator (louise.burke@ausport.gov.au)
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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.
Download to PDF