Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000164594
Ethics application status
Approved
Date submitted
18/01/2024
Date registered
21/02/2024
Date last updated
12/04/2024
Date data sharing statement initially provided
21/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Refeeding Physique Athletes Post-Competition
Scientific title
The effect of refeeding strategies on body composition and resting metabolic rate of physique athletes post-competition.
Secondary ID [1] 311353 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
decreased metabolic rate 332616 0
symptoms associated with low energy availability 332617 0
Condition category
Condition code
Metabolic and Endocrine 329319 329319 0 0
Normal metabolism and endocrine development and function
Diet and Nutrition 329465 329465 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A parallel-group, randomised controlled trial will be conducted to evaluate the effectiveness of refeeding nutrition strategies in physique athletes post-competition. This study will be conducted in accordance with the CONSORT statement for randomised controlled trials.

Approximately 30 male and female natural physique athletes will be recruited to participate in a 9-month study across their competitive season. Participant baseline testing at the beginning of the athlete’s individual competition preparation phase, which generally starts between 20-25 weeks pre-competition. Key observational time points consist of a baseline measure at T0 (20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T2 (1-2 weeks post-competition), T3 (6 weeks post-competition) and T4 (12 weeks post-competition). In the event that a participant plans to compete at multiple competitions spanning greater than 4 weeks between the first and final competition, an additional time point (T1.5) will be added 1-2 weeks prior to their last competition of the season.

Participants will follow the guidance of their own coach leading into competition. After completing their final show of the season, participants will be randomly assigned electronically, by block design into two arms (ARM-1 or ARM-2).

ARM-2 Individualised Dietary Support:
Participants will consult with the lead researcher who is an Accredited Sports Dietitian (CB) to develop an individualised dietetic intervention for 12 weeks post-competition. Daily energy targets will be based on predicted energy requirements (Cunningham Equation and NHMRC Physical Activity Levels) in conjunction with consideration of each athlete’s reported energy intake.

A 30-min counselling session will be held by a research dietitian to educate participants on the use of Easy Diet Diary (EDD) (Xyris Software Australia Pty Ltd) before beginning the study. Training logs (type, timing, intensity using rate of perceived exertion) and food records (kilojoules (kJ) and macronutrients) will be collected for 7-days at T0, T1, and T1.5. Accuracy of entries will be verified at face-to-face laboratory visits.

At T1: A 1-hour face-to-face introductory session will be held to discuss post-competition body composition and health goals with the participant. Immediately post-competition to 12 weeks post-competition, participants will conduct weekly 30-minute phone or Zoom meetings with an Accredited Practicing Dietitian to review progress and provide additional support as required. During this time, participants will track daily dietary intake using EDD and conduct weekly training logs.

Food advice will align with the principles of the Australian Guide to Healthy Eating and evidence-based sports nutrition practice. Each athlete’s food preferences will also be considered. In general, athletes will be encouraged to meet their individualised energy and nutrient goals through consuming a variety of foods from all food groups. Unprocessed foods will be given priority.
Intervention code [1] 327798 0
Treatment: Other
Intervention code [2] 327895 0
Behaviour
Comparator / control treatment
ARM-1 Athlete’s Usual Practice:
Participants will consult with the research dietitian to discuss monitoring their dietary intake for 12 weeks post-competition as follows:

A 30-min counselling session will be held by a research dietitian to educate participants on the use of Easy Diet Diary (EDD) (Xyris Software Australia Pty Ltd) before beginning the study. Training logs (type, timing, intensity using rate of perceived exertion) and food records (kilojoules (kJ) and macronutrients) will be collected for 7-days at T0, T1, and T1.5. Accuracy of entries will be verified at face-to-face laboratory visits.

From the day after competition to 12 weeks post-competition, participants will be asked to report daily dietary intake using EDD and conduct weekly training logs. During this time, weekly 20-minute phone or Zoom meetings will be scheduled with a research dietitian to check compliance with dietary monitoring and verify accuracy of entries.

Participants in this group will not be given any dietary guidance as part of this study. They will be asked to resume their normal practices. They will be free to seek dietary advice from external sources to the study (coach, provoke dietitian etc.) as per their usual practice.
Control group
Active

Outcomes
Primary outcome [1] 337136 0
Primary outcome 1: Body fat
Timepoint [1] 337136 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T3 (6 weeks post-competition) and T4 (primary timepoint, end of intervention, 12-weeks post-competition).
Primary outcome [2] 337137 0
Primary outcome 2: Resting metabolic rate
Timepoint [2] 337137 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T2 (1-2 weeks post-competition), T3 (6 weeks post-competition) and T4 (primary timepoint, end of intervention, 12-weeks post-competition).
Primary outcome [3] 337415 0
Primary outcome 3: Total body weight
Timepoint [3] 337415 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T2 (1-2 weeks post-competition), T3 (6 weeks post-competition) and T4 (primary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [1] 430833 0
Serum thyroid marker: TSH
Timepoint [1] 430833 0
T0 (baseline 20-25 weeks pre-competition),
T1 (1-2 weeks pre-competition),
T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [2] 430834 0
Menstrual function
Timepoint [2] 430834 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T3 (6 weeks post-competition) and T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [3] 430835 0
Pyschological scores - Mood
Timepoint [3] 430835 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T2 (1-2 weeks post-competition), T3 (6 weeks post-competition) and T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [4] 430836 0
Sleep
Timepoint [4] 430836 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T2 (1-2 weeks post-competition), T3 (6 weeks post-competition) and T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [5] 430837 0
Disordered behaviours
Timepoint [5] 430837 0
T0 (baseline 20-25 weeks pre-competition), T2 (1-2 weeks post-competition), T3 (6 weeks post-competition) and T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [6] 430838 0
Strength
Timepoint [6] 430838 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T2 (1-2 weeks post-competition), T3 (6 weeks post-competition) and T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [7] 430839 0
Qualitative experiences
Timepoint [7] 430839 0
T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [8] 431297 0
Lean body mass
Timepoint [8] 431297 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T3 (6 weeks post-competition) and T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [9] 431780 0
Fat free mass
Timepoint [9] 431780 0
T0 (baseline 20-25 weeks pre-competition), T1 (1-2 weeks pre-competition), T3 (6 weeks post-competition) and T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [10] 431782 0
Serum thyroid marker: T3
Timepoint [10] 431782 0
T0 (baseline 20-25 weeks pre-competition),
T1 (1-2 weeks pre-competition),
T4 (secondary timepoint, end of intervention, 12-weeks post-competition).
Secondary outcome [11] 431783 0
Serum thyroid marker: T4
Timepoint [11] 431783 0
T0 (baseline 20-25 weeks pre-competition),
T1 (1-2 weeks pre-competition),
T4 (secondary timepoint, end of intervention, 12-weeks post-competition).

Eligibility
Key inclusion criteria
1. Biologically male or female aged 18-45 years,
2. Have prepared for at least 1 natural bodybuilding show in the past 10 years,
3. Be committed to competing in Season B natural bodybuilding (any category) 2024,
4. Currently >10-15% above estimated stage weight for competition,
5. Have engaged a coach for the competitive season.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any participants under 18 or over 45 years of age.
2. Any participants who declare current or historical use of performance-enhancing substances.
3. Any participants with a history of clinically diagnosed eating disorders.
4. Any participants who are pregnant, breastfeeding, or planning on becoming pregnant within the next year.
5. Any participants with medical conditions and/or taking medications that may affect body weight, body composition, appetite, heart rate, metabolic rate, and/or endocrine function.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be completed by an investigator who has not had contact with participants before randomisation and is not involved in the implementation of interventions. The block sizes will not be disclosed to investigators administering the intervention to ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation process will be used to assign participants, with a 1:1 allocation ratio, to either ARM-1 or ARM-2. Participants will be stratified by sex and age, using permuted blocks of random sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2024
Actual
21/03/2024
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 315609 0
University
Name [1] 315609 0
University of Canberra Research Institute for Sport and Exercise
Country [1] 315609 0
Australia
Primary sponsor type
University
Name
University of Canberra Research Institute for Sport and Exercise
Address
11 Kirinari St, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 317708 0
None
Name [1] 317708 0
Address [1] 317708 0
Country [1] 317708 0
Secondary sponsor category [2] 318482 0
University
Name [2] 318482 0
Australian Catholic University
Address [2] 318482 0
Country [2] 318482 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314497 0
University of Canberra Research Integrity and Ethics
Ethics committee address [1] 314497 0
Ethics committee country [1] 314497 0
Australia
Date submitted for ethics approval [1] 314497 0
28/11/2023
Approval date [1] 314497 0
15/02/2024
Ethics approval number [1] 314497 0

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

Contacts
Principal investigator
Name 131794 0
Miss Claire Buechel
Address 131794 0
University of Canberra Research Institute for Sport and Exercise, Bruce, ACT 2617
Country 131794 0
Australia
Phone 131794 0
+61 433940204
Fax 131794 0
Email 131794 0
[email protected]
Contact person for public queries
Name 131795 0
Claire Buechel
Address 131795 0
University of Canberra Research Institute for Sport and Exercise, Bruce, ACT 2617
Country 131795 0
Australia
Phone 131795 0
+61 433940204
Fax 131795 0
Email 131795 0
[email protected]
Contact person for scientific queries
Name 131796 0
Claire Buechel
Address 131796 0
University of Canberra Research Institute for Sport and Exercise, Bruce, ACT 2617
Country 131796 0
Australia
Phone 131796 0
+61 433940204
Fax 131796 0
Email 131796 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


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.