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Trial registered on ANZCTR


Registration number
ACTRN12622000816752
Ethics application status
Approved
Date submitted
5/05/2022
Date registered
9/06/2022
Date last updated
9/06/2022
Date data sharing statement initially provided
9/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of protein supplementation on IGF-1 and training responses in females
Scientific title
Effects of protein supplementation on IGF-1 and training responses in females
Secondary ID [1] 307063 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aerobic Fitness 326208 0
Muscular Strength 326209 0
Condition category
Condition code
Metabolic and Endocrine 323515 323515 0 0
Normal metabolism and endocrine development and function
Diet and Nutrition 323516 323516 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised control intervention to assess effects of training with post-exercise protein supplementation on IGF-1. Researchers and Post-graduate students will be supervising the small group training, with initial visits one-on-one, in the School of Physical Education Clinic Gym.
Prior to commencement of training 3 separate, pre-training sessions will be conducted for familiarisation and baseline aerobic fitness and lactate threshold, upper body strength and body composition (height. weight. skinfolds girths) measures and to explain diary keeping for diet, exercise and recovery. Two separate appointments will be individually made for baseline blood sampling (day 3-5 menstrual cycle) and DXA scan.
Participants will undergo twelve weeks of mixed training, consisting of upper-body resistance training and cycling interval training. Resistance training will be performed twice weekly, with each resistance training session separated by minimally 48 h. Sessions will take~ 45 min. The exercises will include free-weight exercises, targeting the chest, back, shoulders and arms, and abdomen. All exercises will consist of 8 – 12 repetitions, 3 – 4 sets, with 60 – 90 seconds of rest between each set. Load will be increased according to the "rule of two" progression, specifically, if a participant can perform 2 extra repetitions over the assigned number of repetitions across two consecutive sessions, the load will be increased (Baechle & Earle, 2008).
The three cycling sessions/week will consist of progressive training on a cycle ergometer, using a square-wave mode of intensity training according to Morio et al (British Journal of Nutrition (1998), 80, 511–519). During the first 2 weeks of training, the training exercise will consist of 20 min at heart rate corresponding to 50% VO2max. Thereafter it will comprise interval-training episodes alternating between heart rate corresponding to 50% VO2max for 5 min and heart rate at lactic threshold for 3 min Intensity and duration of the exercise will gradually increase, with the interval-training episodes alternating between heart rate at lactic threshold to heart rate above lactic threshold during the last 6 weeks. There will also be a 10 min low intensity warm-up and 5 min cool-down, therefore sessions will last ~45 min. An electronic spreadsheet in the clinic will be kept for workoads/ progression and participants will also keep attendance in their daily diary (Wild AI app) as well as other information e.g. other daily exercise, indicators of recovery (resting HR, soreness, energy levels), menstruation, and any other notable (eg illness, pharmaceutical use). Cycling sessions will be separated by minimally 24 h. Resistance and cycling sessions will be separated by minimally 8 h.
The first week of training will be 1 to 1 researcher to participant, as will sessions with load increases following 4, 8 week testing. Outside of this will be minimally 1 researcher/assistant to 4 participants.

Participants will be randomly assigned to receive either a high (whey) protein (~25 g) or comparator supplement that will be provided after each training session. Both will be mixed with water in a shaker, provided by the researchers, to be consumed immediately after exercise at the clinic. Empty shaker given back to researchers.
Intervention code [1] 323517 0
Treatment: Other
Comparator / control treatment
Equi-caloric, but very low protein (~5 g), post-exercise supplement (sweet potato powder), mainly carbohydrate
Control group
Dose comparison

Outcomes
Primary outcome [1] 331267 0
Change in plasma IGF-1 concentration
Timepoint [1] 331267 0
Difference between pre-training (baseline) and post-training (12 weeks).
Note: the exact timing may vary slightly for end "week 12 " measure of IGF-1 as menstrual cycle phase affects IGF-1 release and thus blood sample may be collected at week 11 or 13, if 13, then training will be extended.
Primary outcome [2] 331269 0
Body composition; dual-energy X-ray absorptiometry.(DXA)
Timepoint [2] 331269 0
0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training (primary endpoint)
Primary outcome [3] 331270 0
Upper body muscle strength (3 repetition max (3 RM)) for dumbbell shoulder press, dumbbell chest press, dumbbell bench-assisted row
Timepoint [3] 331270 0
0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training (primary endpoint)
Secondary outcome [1] 409366 0
Aerobic Fitness (VO2max) assessed using incremental cycle ergometer test with online respiratory gas analysis.
Timepoint [1] 409366 0
0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training
Secondary outcome [2] 409367 0
Gut microbiome alpha diversity using faecal sample
Timepoint [2] 409367 0
0 (baseline) and 12 weeks post-commencement of training
Secondary outcome [3] 409368 0
resting heart rate -self assessment on brachial artery pulse: count 15 sec. multiply by 4, first thing in morning, still lying in bed., repeat take lowest measure.
Timepoint [3] 409368 0
Daily from 0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training
Secondary outcome [4] 409561 0
Scales of muscle soreness, Likert scale 0-5
Timepoint [4] 409561 0
Daily, before any training on that day, from 0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training
Secondary outcome [5] 409562 0
Subjective energy levels. Likert scale 0-5
Timepoint [5] 409562 0
Daily Likert scale 0-5 from 0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training
Secondary outcome [6] 410190 0
body composition: Skin folds (Harpenden calipers)
Timepoint [6] 410190 0
0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training
Secondary outcome [7] 410191 0
Body composition Bioelectrical Impedance Analysis (BIA)
Timepoint [7] 410191 0
0 (baseline) before training commences, 4, 8, weeks of training. 12 weeks post-commencement of training

Eligibility
Key inclusion criteria
Healthy females having done no resistance training in the last 6 months
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Post-peri-menopausal or amenorrhoeic,
BMI< 18.5 o r>30
On a weight loss programme or intending to lose weight,
Moderate- vigorous exercise > 1 .5 h/ week
any metabolic illness or cancer
maximal exercise contra-indicated (PAR-Q)
on isotretinoin-based medication

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)
Allocated per participant number not name; done apart from recruitment procedures, centrally off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation ((by type of contraceptive use) if not enough recruited on natural menstrual cycles. If enough natural cycle will use simple randomisation (computer random numbers generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based upon work in males (Ives et al., 2017) and change in IGF-1 with 12- weeks training between high and low protein diets (10%), mean, 110 ng/ml and standard deviation 8.5 ng/ml, a sample size of 8 per group was calculated (16 in total) ( a=.05, power= 0.8) (Georgiev G.Z., Sample Size Calculator", https://www.gigacalculator.com/calculators/power-sample-size-calculator.php URL [Accessed Date: 25 Nov, 2021].
We plan to recruit 20 participants to allow for 20% drop-out.
Data will be analysed by linear mixed model analysis of variance, with age, training session, completed and hormonal use or natural cycle as co-variates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2022
Actual
Date of last participant enrolment
Anticipated
16/09/2022
Actual
Date of last data collection
Anticipated
23/12/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 24749 0
New Zealand
State/province [1] 24749 0
otago

Funding & Sponsors
Funding source category [1] 311370 0
University
Name [1] 311370 0
University of Otago
Country [1] 311370 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 312759 0
None
Name [1] 312759 0
Address [1] 312759 0
Country [1] 312759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310860 0
Univeristy of Otago Human Ethics Committee (Health)
Ethics committee address [1] 310860 0
Ethics committee country [1] 310860 0
New Zealand
Date submitted for ethics approval [1] 310860 0
03/12/2021
Approval date [1] 310860 0
22/12/2021
Ethics approval number [1] 310860 0
H21178

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

Contacts
Principal investigator
Name 119126 0
A/Prof Nancy J Rehrer
Address 119126 0
School of Physical Education Sport & Exercise Sciences
University of Otago
PO Box 56
Dunedin 9054
Country 119126 0
New Zealand
Phone 119126 0
+64 34799128
Fax 119126 0
Email 119126 0
nancy.rehrer@otago.ac.nz
Contact person for public queries
Name 119127 0
Nancy J Rehrer
Address 119127 0
School of Physical Education Sport & Exercise Sciences
University of Otago
PO Box 56
Dunedin 9054
Country 119127 0
New Zealand
Phone 119127 0
+64 34799128
Fax 119127 0
Email 119127 0
nancy.rehrer@otago.ac.nz
Contact person for scientific queries
Name 119128 0
Nancy J Rehrer
Address 119128 0
School of Physical Education Sport & Exercise Sciences
University of Otago
PO Box 56
Dunedin 9054
Country 119128 0
New Zealand
Phone 119128 0
+64 34799128
Fax 119128 0
Email 119128 0
nancy.rehrer@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised main outcome variables
When will data be available (start and end dates)?
Upon completion of data analysis and submission for publication; available for 5 years after publication
Available to whom?
Researchers who ask for it
Available for what types of analyses?
Inclusion in meta-analyses
How or where can data be obtained?
From PI < nancy.rehrer@otago.ac.nz>


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.