ANZCTR - Registration

Please note the ANZCTR will be unattended on Monday the 7th of October for the Labour Day public holiday.

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]

none

Universal Trial Number (UTN)

U1111-1233-7454

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Exercise metabolism

Inflammation

Bone health

Gut health

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Inflammatory and Immune System

Normal development and function of the immune system

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Oral and Gastrointestinal

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]

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]

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]

Pre-intervention, 3 weeks post-intervention commencement and 2 weeks post intervention-completion,

Primary outcome [2]

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]

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]

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]

Pre-intervention, 3 weeks post-intervention commencement and 2 weeks post intervention-completion,
Pre and 3 h post 25km Long Walks

Secondary outcome [1]

Bone mineral density - composite outcome

Timepoint [1]

Baseline measure of hip and femur BMD via DXA scans

Secondary outcome [2]

Iron measures (Hb, ferritin, sTfR, transferrin) via venous blood samples
This is a composite outcome of iron status

Timepoint [2]

Pre- and post 3 w dietary periodisation intervention

Secondary outcome [3]

Inflammatory (IL6, hepcidin) response to training session via venous blood samples
This is a composite outcome of inflammation

Timepoint [3]

Pre and 3 h post Long Walks at pre- and post 3 w dietary periodisation intervention

Secondary outcome [4]

Chronic inflammation (CRP, IL6, TNFa) via venous blood samples
This is a composite outcome

Timepoint [4]

Pre and 3 h post Long Walks - pre- and post 3 w dietary periodisation intervention

Secondary outcome [5]

Illness logs (google docs)

Timepoint [5]

Throughout 6 week traning block

Secondary outcome [6]

Blood Lipid profile (cholesterol, triglycerides) via venous blood samples
This is a composite outcome

Timepoint [6]

Pre- and post 3 w dietary periodisation intervention

Secondary outcome [7]

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]

Pre-intervention, 3 weeks post-intervention commencement and 2 weeks post intervention-completion,

Secondary outcome [8]

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]

Measurement of RMR and hormones in Fasted, rested conditions;
Pre- and post 3 w dietary periodisation intervention

Secondary outcome [9]

Body composition (via DXA): lean mass, fat mass
Composite outcome looking at changes in body composition

Timepoint [9]

Pre- and post 3 w dietary periodisation intervention

Secondary outcome [10]

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]

Pre- and post 3 w dietary periodisation intervention

Secondary outcome [11]

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]

Pre- and post 3 w dietary periodisation intervention

Secondary outcome [12]

20 km race
Time to complete will be the main outcome (official race time recorded by race officials will be used)

Timepoint [12]

National championships (Adelaide) – Feb 19
Post study test

Secondary outcome [13]

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]

Throughout 6 week training block

Secondary outcome [14]

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]

2 sessions per week throughout 6 week training block

Secondary outcome [15]

Mental function (stroop color test)

Timepoint [15]

Weekly for 6 weeks: Pre/post hill session

Secondary outcome [16]

Daily training and life quality;
DALDA

Timepoint [16]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

Canada

State/province [2]

Country [3]

Chile

State/province [3]

Country [4]

Italy

State/province [4]

Country [5]

Japan

State/province [5]

Country [6]

Poland

State/province [6]

Country [7]

Finland

State/province [7]

Country [8]

United Kingdom

State/province [8]

Country [9]

South Africa

State/province [9]

Country [10]

Lithuania

State/province [10]

Country [11]

Hungary

State/province [11]

Country [12]

Spain

State/province [12]

Country [13]

United States of America

State/province [13]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

115 Victoria Parade, Fitzroy VIC 3065

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Australian Institute of Sport

Address [2]

Leverrier St, Bruce 2617, ACT

Country [2]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

115 Victoria Parade, Fitzroy VIC 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

AIS ETHICS COMMITTEE

Ethics committee address [1]

Leverrier St, 2617 Bruce, ACT

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/11/2016

Approval date [1]

12/12/2016

Ethics approval number [1]

20161201

Summary

Brief summary

The aim of Supernova 2 is to investigate the effects of 3 weeks adaptation to the LCHF diet and 2 weeks of deadaptation (reintroduction of high CHO diet), on substrate use and subsequent race performance as well as several health related outcomes such as inflammation, iron health, bone health and gut function in world class female and male race walkers.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Louise Burke

Address

Australian Institute of Sport
Leverrier St
2617 Bruce, ACT

Country

Australia

Phone

+61 422 635 869

Fax

louise.burke@ausport.gov.au

Contact person for public queries

Name

Louise Burke

Address

Australian Institute of Sport
Leverrier St
2617 Bruce, ACT

Country

Australia

Phone

+61 422 635 869

Fax

louise.burke@ausport.gov.au

Contact person for scientific queries

Name

Louise Burke

Address

Australian Institute of Sport
Leverrier St
2617 Bruce, ACT

Country

Australia

Phone

+61 422 635 869

Fax

louise.burke@ausport.gov.au

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 (Louise.burke@ausport.gov.au).

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

Source	Title	Year of Publication	DOI
Embase	Crisis of confidence averted: Impairment of exercise economy and performance in elite race walkers by ketogenic low carbohydrate, high fat (LCHF) diet is reproducible.	2020	https://dx.doi.org/10.1371/journal.pone.0234027

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically