Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001502123p
Ethics application status
Submitted, not yet approved
Date submitted
23/10/2019
Date registered
30/10/2019
Date last updated
30/10/2019
Date data sharing statement initially provided
30/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Continued investigation of the effect of low energy availability and low carbohydrate availability on hormone status, metabolism and performance in elite race walkers ('Supernova 5")
Scientific title
Continued investigation of the effect of low energy availability and low carbohydrate availability on hormone status, metabolism and performance in elite race walkers ('Supernova 5")
Secondary ID [1] 299604 0
none
Universal Trial Number (UTN)
U1111-1242-3220
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-performance athlete nutrition 314898 0
Condition category
Condition code
Diet and Nutrition 313243 313243 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 313244 313244 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 313245 313245 0 0
Normal musculoskeletal and cartilage development and function
Blood 313246 313246 0 0
Normal development and function of platelets and erythrocytes
Inflammatory and Immune System 313247 313247 0 0
Normal development and function of the immune system
Oral and Gastrointestinal 313248 313248 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parallel Group design with elite race walkers allocated, according to their preference, to an intervention of short term (5-6 d) exposure to and reversal of:
• Low Energy Availability (LEA: ~15 kcal/kg fat free mass/day, with ideal protein intake to the other diets but reduced carbohydrate and fat intake)
• High Energy/Carbohydrate Availability (Control: ~40 kcal/kg fat-free mass/day; 65% of energy from carbohydrates, ~15% from energy fats, and 2.1g/kg/d protein)
• High Energy/Low Carbohydrate Availability eating (LCHF: 75-80% of energy from fats, <50g/d carbohydrates and 2.1g/kg/d protein)

Detailed methodology:
The Supernova 5 Research camp will be held over a ~4 week period from January 1-February 2, with final information being collected from the 20 km National Race Walking Championships in Adelaide on February 9. Supernova 5 Research camp will be held at the AIS Canberra campus and will involve live-in accommodation in the AIS Residences in which the dietary interventions and training program will be controlled and monitored. Study funding will support the accommodation, meals and training resources needed to implement the study design. A professional chef will provide all meals to ensure that it is an enjoyable experience, and menus will be personalised to the requirements and special needs/preferences of the athletes. We anticipate that most of the participants will have been involved in previous Supernova Research camps and value both the training camp experience/benefits and the embedded research.

Study phases.
Phase 1 (Screening):
On entry to the Supernova 5 camp, we will undertake screening tests to identify baseline characteristics around aerobic capacity, performance and pre-existing markers of energy availability. This will allow us to identify participants who should be excluded from the study due to frank markers of LEA (e.g. consistency in results of low RMR and low fasting hormone concentrations), and to finalise the allocation of athletes into treatment groups based on intervention preferences and matching of key baseline characteristics. Screening tests will involve
• VO2max and economy test according to Supernova 4
• DXA assessment of body composition and bone mineral density
• Measurement of Resting Metabolic Rate
• Screen for fasting concentrations of key hormones (testosterone, estrogen, IGF-1, insulin and T3) to screen for LEA
Baseline + Test Block 1
The commencement of Test Block 1 will be undertaken with the support of a diet with high availability of energy (40 kcal/kg FFM/d) and carbohydrate (65% of energy: 8-10 g/kg/d)
Tests will involve
• VO2max and economy test according to previous Supernova protocols (key change = test to be undertaken after a standardized meal rather than in fasted state)
• For the LCHF group: an additional test session will involve the intake of a ketone ester supplement (HVMN: batch tested commercial supplement with recommended dose of 1 bottle) 60 min prior to a repeat of the economy test (4 stages) to characterise any differences in metabolism due to the supplement
• 10,000 m race walking event conducted by ACT athletics and sanctioned by IAAF (Race 1). This race will be preceded by 24 h of standardised high-carbohydrate, high-energy availability eating, and a high carbohydrate pre-race meal

Harmonisation diet + Completion of Test Block 1:
All participants will be supervised to consume a diet providing high energy availability and high carbohydrate availability to support a structured training program, which will consist of several standardised training sessions (long walk. Hills session, rep session) and sessions of the athlete’s own choosing. This phase will be conducted for 5 d, with the goal of achieving full energy availability for each participant for the completion of Test Block 1. This diet will be continued throughout Test Block 1, and on completion of the testing, participants will then commence their dietary intervention. Block 1 testing will consist of
• DXA/RMR
• 25 km long walk test
• Overnight hormone pulsatility (LH, cortisol and Growth Hormone)
• Fasting metabolic and reproductive hormones (testosterone, estrogen, IGF-1, insulin and T3)
Phase 2 (Intervention)
Participants will be supervised to consume one of three personalised diets (as detailed above).
Participants will continue to consume these diets for the commencement of Block 2 testing. Test Block 2 will repeat the tests involved in Block 1:
• VO2max/economy test (to profile metabolism over a range of exercise intensities as a result of the dietary treatments)
• For the LCHF group: an additional test session will repeat the intake of a ketone ester supplement (HVMN: batch tested commercial supplement with recommended dose of 1 bottle) 60 min prior to a repeat of the economy test (4 stages) to characterise any changes in metabolism due to the supplement following adaptation to a ketogenic diet
• DXA/RMR
• 25 km long walk test
• Overnight hormone pulsatility (LH, cortisol and Growth Hormone)
• Fasting metabolic and reproductive hormones (testosterone, estrogen, IGF-1, insulin and T3)
• Race 2. Race 2 will involve the same protocol as Race 1, with
o LEA subjects resuming 24 h of standardised high-carbohydrate, high-energy availability eating and a high carbohydrate pre-race meal. This will allow us to confirm the findings of Supernova 4 that the potential performance disadvantages of the intervention diets can be overturned by 24 h of restored energy/carbohydrate availability. Indeed, there may be net benefits due to loss of BM or enhanced fat oxidation in concert with restored fuel status.
o LCHF subjects will remain on the LCHF diet and will consume a bottle of the ketone ester supplement to investigate the benefits of this supplement on higher intensity endurance performance

Phase 3 (Refeeding)
In this phase, all participants will resume 5 d of high energy/high carbohydrate diet (i.e. the Control HCHO diet) to fully restore fuel availability before departing the camp. The final test will involve a recheck of the restoration of any hormonal perturbations due to the intervention diets
• Fasting metabolic and reproductive hormones (testosterone, estrogen, IGF-1, insulin and T3)
Post-camp
It is anticipated that most participants will race in the 2020 Australian Road Racing 20 km championships in Adelaide on February 9. Participants will be invited to record their self-chosen dietary intake and training in preparation for this race. Researchers will provide support for participants during the race (feeding from aid stations) and record race behaviours (fluid intake, carbohydrate intake, BM changes) and outcomes to provide feedback about the achievement of their self-chosen race nutrition goals. This will form descriptive information on practices of elite endurance athletes during race conditions, and provide opportunity for insight into the effect of the camp involvement on race performance
Intervention code [1] 315859 0
Other interventions
Comparator / control treatment
High energy/high carbohydrate availability (HCHO): This diet is essentially the HCHO treatment that has served as the control for the previous SN research camps. It provides an energy availability of ~ 40 kcal/kg LBM/d and is typically ~ 225 kJ/kg BM/d energy, 8.5 g/kg/d carbohydrate and ~ 2 g/kg protein). Note that this is adjusted to increase energy/carb content for participants with an increased training
Control group
Active

Outcomes
Primary outcome [1] 321738 0
Pulsatility of LH over an 8h venous blood sampling period (samples will be drawn every 20min).
Timepoint [1] 321738 0
Before and after Phase 3 (intervention)
Primary outcome [2] 321739 0
Pulsatility of GH over an 8h venous blood sampling period (samples will be drawn every 20min).
Timepoint [2] 321739 0
Before and after Phase 3 (intervention)
Primary outcome [3] 321740 0
Bone metabolism
(CTX, PINP, OC)
This is a composite outcome

Venous blood samples will be collected and analysed using ELISA kits.
Timepoint [3] 321740 0
During 25 km walks (takes place Before and after Phase 3 (intervention)) at time points:
Fasting (120min before exercise)
Immediately before exercise
Immediately after exercise
1h after exercise
3h after exercise
Secondary outcome [1] 376055 0
Exercise economy will be assessed using a ramp test protocol within a single treadmill test called VO2max test
Timepoint [1] 376055 0
Before Phase 2 (harmonisation)
After Phase 3 (intervention)
Secondary outcome [2] 376056 0
10,000m race to measure performance
Timepoint [2] 376056 0
In the middle of screening (pre)
After phase 3 (intervention) (post)
Secondary outcome [3] 376057 0
DXA for bone mineral density
measured using Dual X-ray Absorptiometry
Timepoint [3] 376057 0
Before phase 3 (intervention)
Secondary outcome [4] 376058 0
LEAM-Q questionnaire
Timepoint [4] 376058 0
During screening
Secondary outcome [5] 376059 0
Fasting blood testosterone
Timepoint [5] 376059 0
During screening, before and after intervention, and after refeed
Secondary outcome [6] 376060 0
10-point Likert Scale for self-reported gastrointestinal symptoms (see https://www.ncbi.nlm.nih.gov/pubmed/28177715)
Timepoint [6] 376060 0
during 25 km long walks
At rest and after every 5 km lap, as well as post-exercise.
Secondary outcome [7] 376061 0
DXA for body composition
measured using Dual X-ray Absorptiometry
Timepoint [7] 376061 0
Before and after intervention
Secondary outcome [8] 376062 0
Depression Anxiety and Stress Scales (DASS) periodically
Timepoint [8] 376062 0
(weekly/end of diet blocks)
Secondary outcome [9] 376063 0
Validated Psychological questionnaires around well-being at the end of each dietary phase (REST-Q)
Timepoint [9] 376063 0
after 5d diet intervention blocks
Secondary outcome [10] 376064 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [10] 376064 0
daily
Secondary outcome [11] 376066 0
Fasting blood IGF-1
Timepoint [11] 376066 0
During screening, before and after intervention, after refeed
Secondary outcome [12] 376067 0
Fasting blood insulin
Timepoint [12] 376067 0
During screening, before and after intervention, after refeed
Secondary outcome [13] 376068 0
Fasting blood T3
Timepoint [13] 376068 0
During screening, before and after intervention, after refeed
Secondary outcome [14] 376070 0
25 km long walk protocol to assess substrate metabolism (i.e. CHO and fat oxidation)
This is a hybrid laboratory/field test at ~75%VO2max.
Substrate metabolism during exercise:
Free fatty acids and insulin, ketones and glucose
This is a composite outcome
Timepoint [14] 376070 0
During 25 km walks at time points:
Fasting (120min before exercise)
Immediately before exercise
Immediately after exercise
1h after exercise
3h after exercise
Secondary outcome [15] 376071 0
Testosterone/cortisol ratio

venous blood samples for analysis of testosterone and cortisol.
Timepoint [15] 376071 0
During 25 km walks at time points:
Fasting (120min before exercise)
Immediately before exercise
Immediately after exercise
1h after exercise
3h after exercise
Secondary outcome [16] 376096 0
Iron metabolism (hepcidin, ferritin) Venous blood samples will be drawn to assess iron parameters.
This is a composite outcome
Timepoint [16] 376096 0
During 25 km walks at time points: Fasting (120min before exercise) Immediately before exercise Immediately after exercise 1h after exercise 3h after exercise
Secondary outcome [17] 376097 0
Gut permeability: I-FABP, claudin, LPS, LBP, sCD14 Venous blood samples will be drawn to assess markers of gut permeability

This is a composite outcome
Timepoint [17] 376097 0
During 25 km walks at time points: Fasting (120min before exercise) Immediately before exercise Immediately after exercise 1h after exercise 3h after exercise
Secondary outcome [18] 376098 0
Immune/inflammatory markers (IL-6) Venous blood samples for analysis of IL6
Timepoint [18] 376098 0
During 25 km walks at time points: Fasting (120min before exercise) Immediately before exercise Immediately after exercise 1h after exercise 3h after exercise
Secondary outcome [19] 376099 0
Metabolome Venous blood samples for analysis the metabolome
This is an exploratory outcome
Timepoint [19] 376099 0
During 25 km walks at time points: Fasting (120min before exercise) Immediately before exercise Immediately after exercise 1h after exercise 3h after exercise
Secondary outcome [20] 376100 0
Venous blood nitrate and nitrite concentrations

This is a composite outcome
Timepoint [20] 376100 0
Before and after beetroot juice challenge on the mornings after overnight hormone collection
Secondary outcome [21] 376163 0
Fecal sample to measure gut microbiota
Timepoint [21] 376163 0
During screening
After intervention
Secondary outcome [22] 376164 0
Hemoglobin mass
(via carbon monoxide rebreathing method)
Timepoint [22] 376164 0
Screening
After Refeed
Secondary outcome [23] 376356 0
RMR
measured using Douglas bag analysis
Timepoint [23] 376356 0
At the end of:
Phase 2 (harmonisation)
Phase 3 (intervention)
Secondary outcome [24] 376357 0
Pulsatility of cortisol over an 8h venous blood sampling period (samples will be drawn every 20min).
Timepoint [24] 376357 0
Before and after Phase 3

Eligibility
Key inclusion criteria
Elite male race walkers who meet criteria to compete in IAAF sanctioned national and international standard races and are in training for the 2020 season.
We anticipate that most of these athletes will have participated in previous Supernova studies
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Race walkers with diagnosed medical conditions involving thyroid function or other chronic disturbances of metabolic rate
Race walkers with symptoms of severe chronic LEA/RED-S (e.g. suppressed metabolic rate, low BMD)
Race walkers who are unable to complete the training or testing protocols

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
Our previous studies have found that sufficient power is provided by 8 participants per group.

LMM willl be used to analyse the effects of treatments on various outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
9/02/2020
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21941 0
New Zealand
State/province [1] 21941 0
Country [2] 21942 0
Canada
State/province [2] 21942 0
Country [3] 21943 0
Chile
State/province [3] 21943 0
Country [4] 21944 0
Colombia
State/province [4] 21944 0
Country [5] 21945 0
Japan
State/province [5] 21945 0
Country [6] 21946 0
United Kingdom
State/province [6] 21946 0
Country [7] 21947 0
United States of America
State/province [7] 21947 0
Country [8] 21948 0
Sweden
State/province [8] 21948 0
Country [9] 21949 0
Mexico
State/province [9] 21949 0
Country [10] 21950 0
Poland
State/province [10] 21950 0

Funding & Sponsors
Funding source category [1] 304082 0
University
Name [1] 304082 0
Australian Catholic University
Country [1] 304082 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade, Fitzroy Vic 3065

Locked Bag 4115, Fitzroy MDC Fitzroy Vic 3065
Country
Australia
Secondary sponsor category [1] 304289 0
Government body
Name [1] 304289 0
Athletics Australia
Address [1] 304289 0
Athletics Australia
Athletics House
Level 2, 31 Aughtie Drive
Albert Park VIC 3206
Country [1] 304289 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304573 0
Ethics Committee of Australian Institute of Sport
Ethics committee address [1] 304573 0
Ethics committee country [1] 304573 0
Australia
Date submitted for ethics approval [1] 304573 0
28/10/2019
Approval date [1] 304573 0
Ethics approval number [1] 304573 0

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

Contacts
Principal investigator
Name 97434 0
Prof Louise Burke
Address 97434 0
AIS Sports Nutrition
PO box 176
2617 Belconnen ACT
Country 97434 0
Australia
Phone 97434 0
+61 2 6214 1351
Fax 97434 0
Email 97434 0
louise.burke@ausport.gov.au
Contact person for public queries
Name 97435 0
Louise Burke
Address 97435 0
AIS Sports Nutrition
PO box 176
2617 Belconnen ACT
Country 97435 0
Australia
Phone 97435 0
+61 2 6214 1351
Fax 97435 0
Email 97435 0
louise.burke@ausport.gov.au
Contact person for scientific queries
Name 97436 0
Louise Burke
Address 97436 0
AIS Sports Nutrition
PO box 176
2617 Belconnen ACT
Country 97436 0
Australia
Phone 97436 0
+61 2 6214 1351
Fax 97436 0
Email 97436 0
louise.burke@ausport.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Athletes will receive their individual test result as they are available during the study. It will be up to them to share their personal data with the others. Only group data will be reported in scientific/lay publications


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.