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Trial registered on ANZCTR


Registration number
ACTRN12618001919202p
Ethics application status
Not yet submitted
Date submitted
21/11/2018
Date registered
26/11/2018
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in Hormones: Does consuming protein or exercising influence the hormones of healthy adults?
Scientific title
Protein, Exercise, and Insulin Like Growth Factor-1 Response in Healthy Adults: Can the time-course and magnitude of response be altered?
Secondary ID [1] 296640 0
Nil known
Universal Trial Number (UTN)
U1111-1224-2545
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Protein metabolism 310482 0
Condition category
Condition code
Metabolic and Endocrine 309194 309194 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Repeated measures three way randomized cross-over design with three conditions and 24 participants. The three conditions are: exercise only, protein only, and exercise with protein. Participants will be randomly assigned to complete the three interventions in one of six possible orders. Interventions will be conducted at the same time of day, separated by a minimum of one week.

Materials: Anthropometric measurement tools (scale, tape measure, bio-electrical impedance device for body composition), cycle ergometer (for VO2 max test and exercise condition), metabolic cart (for VO2 max gas exchange), protein smoothie (for high protein intervention), Low protein high carbohydrate smoothie (for isocaloric placebo), standardized full meal for after all interventions (pizza or allergen free equivalent).

Supplement Details:
High Protein (30g) Supplement Composition: 30g whey isolate protein powder mixed with 30g of carbohydrate in the form of 8 oz almond milk (2g CHO), 1 banana (23g CHO), 8g chocolate syrup (5g CHO) all blended together to form a chocolate banana smoothie with approximately 1004 kJoules of energy.

Low Protein (0g) Supplement Composition: 60g of carbohydrates in the form of 8 oz almond milk (2g CHO), 1 banana (23g CHO), 53g chocolate syrup (35g CHO) all blended together to form a chocolate banana smoothie with approximately 1004 kJoules of energy.

Procedures:
Initial Testing Session
After providing written informed consent, and at least one week prior to participating in the first intervention session, anthropometric measurements and bio-electrical impedance analysis for body composition will be conducted. A maximal oxygen capacity (VO2max) test will then be conducted on a cycle ergometer to determine training status of the participants.
This will take approximately 12-15 min, in which intensity is increased in a graded fashion while respiratory gas analysis is conducted. The test will be administered by a trained exercise physiologist (Colleen Gulick).
Participants will also fill out a Physical Activity Readiness Questionnaire (PAR-Q) to assess suitability to perform maximal exercise and reduce risk. An exercise history questionnaire will also be completed to determine the amount of exercise they have been performing in the previous three months.

Protein Trial
Participants will report to the testing facility at 6:30 am after a 10-hour overnight fast. The researcher will confirm that the participant did not exercise for the past 24 hours. After these confirmations the participant will remain seated until 6:45 am, at which point the baseline blood samples will be drawn. The participant will remain seated until 7:30am. Between 7:30 and 7:35am the participant will consume a single dose of a high protein meal. The protein meal will be comprised of 30 g of protein and 30 g of carbohydrate (whey isolate protein powder mixed with fruit smoothie base for taste) totaling 1004 kJoules. A post-intervention blood draw will occur at 7:35 am. From 7:35 am to 10 am the participant will remain seated at the testing site and blood measurements will be conducted every 30 minutes. After 2.5 hours the blood draws will be reduced to one 5mL draw per hour. Participants will be asked to refrain from performing any exercise or eating until the final blood draw of the day (14:00). At 14:05 the participants will be provided with a standardized meal consisting of frozen pizza (or allergen-free equivalent).

The following morning the participant will report back to the testing facility and provide a blood sample (via venipuncture) at 7:00 am to see when/if the IGF-1 and IGFBP3 concentrations return to normal after the trial.

Exercise Trial
The protocol will be the same as described in “Protein Intervention” however, no protein will be consumed between 7:30 am and 7:35 am. Instead, at 7:05 am the participant will perform a 20-minute exercise protocol based on the results of their initial testing session. The exercise will consist of four cycles of: 4 minutes at 15% of aerobic threshold power followed by 30 seconds of maximum effort. The session will end with 2 minutes at 15% aerobic threshold power. Participants will be given an iso-caloric placebo meal consisting of 0 g protein and 60 g of carbohydrate (fruit smoothie) at 7:30 am. In this way the caloric intake will be controlled between all trials and any affects will be a result of protein ingestion.

Exercise and Protein Trial
The protocol will be the same as described in “Protein Intervention” however, exercise will be conducted between 7:05 am and 7:30 am before consumption of the single high protein (30 g) supplement between 7:30 am and 7:35 am.
Supplement Details: High Protein (30g) Supplement Composition: 30g whey isolate protein powder mixed with 30g of carbohydrate in the form of 8 oz almond milk (2g CHO), 1 banana (23g CHO), 8g chocolate syrup (5g CHO) all blended together to form a chocolate banana smoothie with approximately 1004 kJoules of energy.

Who: Exercise physiologist (to deliver intervention) & research nurse (perform cannulation)
Mode of Delivery: face to face delivery. Interventions may be conducted as a group if scheduling permits but each participant will adhere to their own individualized and randomized intervention.
Number of Times: 3 sessions (once per week)
Duration: 7 hours each session
Location: University of Otago, Dunedin, New Zealand
Intervention code [1] 312959 0
Early detection / Screening
Intervention code [2] 312960 0
Behaviour
Intervention code [3] 312961 0
Lifestyle
Comparator / control treatment
This is a crossover study where participants act as their own control. The exercise only condition will be used as the control.
Control group
Active

Outcomes
Primary outcome [1] 308188 0
Insulin Like Growth Factor-1 (IGF-1) Area Under the Curve assessed using total plasma ab211651 Human IGF1 SimpleStep ELISA Kit.
Timepoint [1] 308188 0
Time points:(IGF-1): -t30min, 0min, every 30 min until 2.5 hours post intervention, then hourly until 6.5 hours post intervention. Then 23.5 hours post intervention.
Secondary outcome [1] 354242 0
Insulin Like Growth Factor Binding Protein 3 (IGFBP3) Area Under the Curve assessed using total plasma ab211652 Human IGFBP3 SimpleStep ELISA Kit.
Timepoint [1] 354242 0
Time points:(IGFBP3): -t30min, 0min, every 30 min until 2.5 hours post intervention, then hourly until 6.5 hours post intervention. Then 23.5 hours post intervention.

Eligibility
Key inclusion criteria
To be included in the study participants will:
• have a BMI < 35
• be physically capable of participating in physical activity as indicated by Physical Activity Readiness Questionnaire score that indicates maximal exercise ill advised
• be aged between 18 and 65 y
• speak and understand English
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- not be on any medication (besides birth control pills, vitamins/ minerals)
- not have Diabetes, cardiovascular disease or other known or identifiable disease state, disease
- not be pregnant or planning a pregnancy
- not be lactose intolerant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 24 participants will provide 80% power to detect a treatment effect of a 0.5 standard deviation difference in mean IGF-1 area under the curve, assuming a within participant correlation of 0.7 and a = 0.05. Both incremental and total area under the curve will be calculated for IGF-1 and IGFBP3 concentration using the trapezoidal rule. This summary measure will be compared between conditions using mixed model regression with a random participant effect to control for multiple measures in each participant. Results will be considered statistically significant at P < 0.05.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2019
Actual
Date of last participant enrolment
Anticipated
1/03/2019
Actual
Date of last data collection
Anticipated
8/04/2019
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 21057 0
New Zealand
State/province [1] 21057 0
Otago

Funding & Sponsors
Funding source category [1] 301219 0
University
Name [1] 301219 0
University of Otago, Dunedin
Country [1] 301219 0
New Zealand
Primary sponsor type
Individual
Name
Assoc Prof Nancy Rehrer
Address
University of Otago
School of Physical Education, Sport & Exercise Sciences, PO Box 56, Dunedin NZ 9054
Country
New Zealand
Secondary sponsor category [1] 300854 0
Individual
Name [1] 300854 0
Colleen Gulick
Address [1] 300854 0
University of Otago
School of Physical Education, Sport & Exercise Sciences, PO Box 56, Dunedin NZ 9054
Country [1] 300854 0
New Zealand
Other collaborator category [1] 280440 0
Individual
Name [1] 280440 0
Dr. Meredith Peddie
Address [1] 280440 0
Department of Human Nutrition, University of Otago
PO Box 56
Dunedin, NZ 9054
Country [1] 280440 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301964 0
University of Otago
Ethics committee address [1] 301964 0
Ethics committee country [1] 301964 0
New Zealand
Date submitted for ethics approval [1] 301964 0
03/12/2018
Approval date [1] 301964 0
Ethics approval number [1] 301964 0

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

Contacts
Principal investigator
Name 88690 0
A/Prof Nancy Rehrer
Address 88690 0
School of Physical Education, Sport & Exercise Sciences
PO Box 56
Dunedin, NZ 9054
Country 88690 0
New Zealand
Phone 88690 0
+64 3 479 9128
Fax 88690 0
Email 88690 0
Nancy.rehrer@otago.ac.nz
Contact person for public queries
Name 88691 0
Colleen Gulick
Address 88691 0
University of Otago
School of Physical Education, Sport & Exercise Sciences
PO Box 56
Dunedin, NZ 9054
Country 88691 0
New Zealand
Phone 88691 0
+64 210 393039
Fax 88691 0
Email 88691 0
Gulco757@student.otago.ac.nz
Contact person for scientific queries
Name 88692 0
Colleen Gulick
Address 88692 0
University of Otago
School of Physical Education, Sport & Exercise Sciences
PO Box 56
Dunedin, NZ 9054
Country 88692 0
New Zealand
Phone 88692 0
+64 210393039
Fax 88692 0
Email 88692 0
Gulco757@student.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?
unidentified participant data will be made available upon request for potential future meta-analyses
When will data be available (start and end dates)?
immediately following publication, no end date
Available to whom?
available to researchers that are conducting meta-analyses upon request
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
provided by principal investigator on password protected device or by password protected mechanism


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.