Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001974291p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2018
Date registered
7/12/2018
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of low energy availability and low carbohydrate availability on hormone status, metabolism and performance in elite race walkers ('Supernova 4")
Scientific title
The effect of low energy availability and low carbohydrate availability on hormone status, metabolism and performance in elite race walkers ('Supernova 4")
Secondary ID [1] 296699 0
ACURF
Universal Trial Number (UTN)
U1111-1224-5719
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-performance athlete nutrition 310547 0
Reproductive hormones (testosterone, LH) 310548 0
Bone metabolism 310549 0
Metabolic hormones (T3, IGF1. leptin, cortisol) 310594 0
Condition category
Condition code
Diet and Nutrition 309259 309259 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 309260 309260 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 309309 309309 0 0
Normal musculoskeletal and cartilage 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: ~20 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 4 Research camp will be held over a ~4 week period from January 3-February 3, with final information being collected from the 20 km National Race Walking Championships in Adelaide on February 10. Supernova 4 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 4 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 previous Supernova protocols (key change = test to be undertaken after a standardized meal rather than in fasted state)
• 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
• 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
Phase 2 (Harmonisation):
All participants will be supervised to consume a Control diet as described above 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 baseline test block (Test 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
• Hormone profiling/BJ challenge
Phase 2 (Intervention)
Participants will be supervised to consume one of three personalised diets: LEA, LCHF or Control. 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, with the addition of:
• VO2max/economy test (to profile metabolism over a range of exercise intensities as a result of the dietary treatments)
• Race 2. Race 2 will involve the same protocol as Race 1, with all subjects resuming 24 h of standardised high-carbohydrate, high-energy availability eating and a high carbohydrate pre-race meal.
Phase 3 (Refeeding)
In this phase, all participants will resume 5 d of high energy/high carbohydrate diet (i.e. the Control diet)to fully restore fuel availability before undertaking Test Block 3. Test block 3 will be a repeat of Test Block 1, to investigate whether any pertubations in body systems identified in Test Block 2 can be reversed in a similar time period
Post-camp
It is anticipated that most participants will race in the 2019 Australian Road Racing 20 km championships in Adelaide on February. 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

Test Protocols:
To avoid the need for an excessively lengthy ethics application and to aid in understanding the project as a whole, this application will provide an abbreviated description of data collection within the 5 testing protocols , with the identification of new testing variables and study collaborations not previously involved in SN 1-3.
1. DXA and RMR: Duplicate measurements of Resting Metabolic Rate will be undertake on participants under fasting, resting conditions according to AIS Best Practice Protocols. This will be followed by a DXA assessment of body composition also undertaken according to AIS Best Practice Protocols by an accredited DXA technician. Bioimbedance will be used to estimate total body water at the same time to check for artefacts in the DXA measurements of Lean Body Mass created by the loss of muscle glycogen and its bound water stores. This protocol will allow us to investigate the true effects of the dietary interventions on resting metabolic rate, as well as determine whether a potential artefact can cause a false interpretation.
2. 10,000 m race. Athletes will consume a standardised high carbohydrate pre-race meal (2 h pre-race) and follow their self-chosen race warm up/preparation strategies.
• In the case of the LCHF diet group, the warm up will include a brief laboratory test of economy and fuel utilisation at 2 exercise intensities, to allow the investigation of changes achieved separately by the 6 d of LCHF diet and 24 h restoration of glycogen. Race logistics do not allow this information to be collected from all participants; and prioritisation will be given to the LCHF group since the capacity of “fat-adapted” muscle to utilise glycogen if it is restored remains an unresolved issue. In this case, direct comparison can be made between the VO2max test days and the Race days, to show shifts in muscle fuel use due to chronic adaptation and acute fuel stores
• All participants will provide capillary blood samples to monitor glucose, lactate and ketones pre, and post-race
3. VO2max/economy test
Participants will consume a meal according to their dietary phase (e.g. Control or intervention), 2 h prior to the test. The test will involve the standard 4 stage + ramp to fatigue undertaken in previous SN camps and as routinely used in distance athletics in Australia
• Capillary blood samples will be collected post-meal and at the end of each stage of the test to measure blood metabolites
4. 25 km long walk protocol
• Hybrid Lab-Field test with segments in laboratory and remainder as 5 km loops around AIS
• 5 min lab (~1 km) segments (0-1, 6-7, 12-13, 18-19, 24-25 km) to monitor fuel use and economy at 2nd speed of economy test (~ 50 km race speed)
• A mixture of venous and capillary blood samples will be taken to minimise total blood volume and allow investigation of a range of variables
• New parameters add to 25 km walk test: Metabolome; Reticulocytes for Athlete Biological passport; Salivary/Blood testosterone and cortisol.
5. Hormonal profiling and Beetroot juice challenge: Participants will be observed for a 6-7 h period at rest, involving early morning and fasted blood samples (hormone pulsatility), plus the response to a meal and a beetroot juice supplement challenge.
In addition to blood samples, we will collect fecal and saliva samples for investigation of changes in the microbiome.
Intervention code [1] 313014 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] 308248 0
RMR
measured using Douglas bag analysis
Timepoint [1] 308248 0
At the beginning of:
Phase 1 (screening)

At the end of:
Phase 2 (harmonisation)
Phase 3 (intervention)
Phase 4 (refeeding)
Primary outcome [2] 308249 0
25 km long walk protocol to assess bone and calcium metabolism (CTX, PINP, OC).
This is a hybrid laboratory/field test at ~75%VO2max.
Timepoint [2] 308249 0
At the end of:
Phase 2 (harmonisation)
Phase 3 (intervention)
Phase 4 (refeeding)
Primary outcome [3] 308250 0
Bone metabolism
(CTX, PINP, OC)

Venous blood samples will be collected and analysed using ELISA kits.
Timepoint [3] 308250 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 [1] 354393 0
Exercise economy will be assess using a ramp test protocol within a single treadmill test called VO2max test
Timepoint [1] 354393 0
Phase 1 (screening)
At the end of Phase 3 (intervention)
At the end of phase 4 (refeeding)
Secondary outcome [2] 354394 0
10,000m race to measure performance
Timepoint [2] 354394 0
in the middle of screening (pre)
after 1 day of refeeding (post)
Secondary outcome [3] 354395 0
Pulsatility of testosterone over a 6h venous blood sampling period (samples will be drawn every 30min).
Timepoint [3] 354395 0
During harmonisation (pre)
After intervention (post)
Includes 6h of continuous blood sampling at 30min intervals
Secondary outcome [4] 354396 0
LEAM-Q questionnaire
Timepoint [4] 354396 0
on entry to camp
Secondary outcome [5] 354483 0
Iron metabolism (hepcidin, ferritin)

Venous blood samples will be drawn to assess iron parameters.
Timepoint [5] 354483 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 [6] 354484 0
Gut permeability: I-FABP, claudin, LPS, LBP, sCD14

Venous blood samples will be drawn to assess markers of gut permeability
Timepoint [6] 354484 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 [7] 354485 0
Testosterone/cortisol ratio

Venous blood samples for analysis of testosterone and cortisol.
Timepoint [7] 354485 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 [8] 354486 0
Immune/inflammatory markers (IL-6)
Venous blood samples for analysis of IL6
Timepoint [8] 354486 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 [9] 354487 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
Timepoint [9] 354487 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 [10] 354488 0
Metabolome

Venous blood samples for analysis the metabolome
Timepoint [10] 354488 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 [11] 354528 0
DXA for bone mineral density
measured using Dual X-ray Absorptiometry
Timepoint [11] 354528 0
At baseline and after each dietary phase
Secondary outcome [12] 354530 0
Pulsatility of LH over a 6h venous blood sampling period (samples will be drawn every 30min).
Timepoint [12] 354530 0
During harmonisation (pre)
After intervention (post)
Includes 6h of continuous blood sampling at 30min intervals
Secondary outcome [13] 354531 0
Pulsatility of IGF1 over a 6h sampling period.

Venous blood samples every 30min.
Timepoint [13] 354531 0
During harmonisation (pre)
After intervention (post)
Includes 6h of continuous blood sampling at 30min intervals
Secondary outcome [14] 354532 0
Pulsatility of insulin
venous blood samples
Timepoint [14] 354532 0
During harmonisation (pre)
After intervention (post)
Includes 6h of continuous blood sampling at 30min intervals
Secondary outcome [15] 354533 0
Thyroid hormone T3 resting values
venous blood samples
Timepoint [15] 354533 0
During harmonisation (pre)
After intervention (post)
Secondary outcome [16] 354536 0
10-point Likert Scale for self-reported gastrointestinal symptoms (see https://www.ncbi.nlm.nih.gov/pubmed/28177715)
Timepoint [16] 354536 0
during 25 km long walks
At rest and after every 5 km lap, as well as post-exercise.
Secondary outcome [17] 354677 0
DXA for body composition
measured using Dual X-ray Absorptiometry
Timepoint [17] 354677 0
BAseline and after each phase
Secondary outcome [18] 354686 0
Mini-International Neuropsychiatric Interview (MINI)
Timepoint [18] 354686 0
at baseline.
Secondary outcome [19] 354687 0
Depression Anxiety and Stress Scales (DASS) periodically
Timepoint [19] 354687 0
(weekly/end of diet blocks)
Secondary outcome [20] 354688 0
Acute Recovery Stress Scale (ARSS)
Timepoint [20] 354688 0
after 5d diet intervention blocks
Secondary outcome [21] 354689 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [21] 354689 0
daily
Secondary outcome [22] 354690 0
Hamstring strength test (5-7minutes per person)
Timepoint [22] 354690 0
at the end of each diet phase

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 2019 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 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
12/12/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
10/02/2019
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21073 0
New Zealand
State/province [1] 21073 0
Country [2] 21074 0
Canada
State/province [2] 21074 0
Country [3] 21075 0
Chile
State/province [3] 21075 0
Country [4] 21076 0
Colombia
State/province [4] 21076 0
Country [5] 21077 0
Japan
State/province [5] 21077 0
Country [6] 21078 0
Mexico
State/province [6] 21078 0
Country [7] 21079 0
Poland
State/province [7] 21079 0
Country [8] 21080 0
Slovakia
State/province [8] 21080 0
Country [9] 21081 0
South Africa
State/province [9] 21081 0
Country [10] 21082 0
Sweden
State/province [10] 21082 0
Country [11] 21083 0
Lithuania
State/province [11] 21083 0

Funding & Sponsors
Funding source category [1] 301279 0
University
Name [1] 301279 0
Australian Catholic University
Country [1] 301279 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] 300926 0
Government body
Name [1] 300926 0
Athletics Australia
Address [1] 300926 0
Athletics Australia
Athletics House
Level 2, 31 Aughtie Drive
Albert Park VIC 3206
Country [1] 300926 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302023 0
Ethics Committee of Australian Institute of Sport
Ethics committee address [1] 302023 0
Sport Australia
Leverrier Street
Bruce ACT 2617
PO Box 176
BELCONNEN ACT 2616
Ethics committee country [1] 302023 0
Australia
Date submitted for ethics approval [1] 302023 0
26/11/2018
Approval date [1] 302023 0
Ethics approval number [1] 302023 0

Summary
Brief summary
Low energy availability is a major topic in sports nutrition. The increased risk of illness and injury associated with Low energy availability interferes with athlete availability and directly contributes to sub-optimal adaptation and competition performance. We now recognise an increased array of problems associated with chronic and/or severe Low energy availability in male athletes. Therefore, greater knowledge of the effects of reduced LEA on various body systems is required to allow better education, prevention and management of damaging scenarios, while assisting athletes to be able to include shorter periods of tolerable reductions of EA within their programs. The Supernova 4 research camp will investigate the effect of low energy availability and its reversal on a variety of markers of body systems at rest and in interaction with exercise on a cohort of elite male endurance athletes (race walkers).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88870 0
Prof Louise Burke
Address 88870 0
AIS Sports Nutrition
PO box 176
2617 Belconnen ACT
Country 88870 0
Australia
Phone 88870 0
+61 2 6214 1351
Fax 88870 0
Email 88870 0
[email protected]
Contact person for public queries
Name 88871 0
Prof Louise Burke
Address 88871 0
AIS Sports Nutrition
PO box 176
2617 Belconnen ACT
Country 88871 0
Australia
Phone 88871 0
+61 2 6214 1351
Fax 88871 0
Email 88871 0
[email protected]
Contact person for scientific queries
Name 88872 0
Prof Louise Burke
Address 88872 0
AIS Sports Nutrition
PO box 176
2617 Belconnen ACT
Country 88872 0
Australia
Phone 88872 0
+61 2 6214 1351
Fax 88872 0
Email 88872 0
[email protected]

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.