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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?
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Scientific title
Protein, Exercise, and Insulin Like Growth Factor-1 Response in Healthy Adults: Can the time-course and magnitude of response be altered?
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Secondary ID [1]
296640
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Nil known
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Universal Trial Number (UTN)
U1111-1224-2545
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Protein metabolism
310482
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Condition category
Condition code
Metabolic and Endocrine
309194
309194
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0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
312959
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Early detection / Screening
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Intervention code [2]
312960
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Behaviour
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Intervention code [3]
312961
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Insulin Like Growth Factor-1 (IGF-1) Area Under the Curve assessed using total plasma ab211651 Human IGF1 SimpleStep ELISA Kit.
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Assessment method [1]
308188
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Timepoint [1]
308188
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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.
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Secondary outcome [1]
354242
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Insulin Like Growth Factor Binding Protein 3 (IGFBP3) Area Under the Curve assessed using total plasma ab211652 Human IGFBP3 SimpleStep ELISA Kit.
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Assessment method [1]
354242
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Timepoint [1]
354242
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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.
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/01/2019
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Actual
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Date of last participant enrolment
Anticipated
1/03/2019
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Actual
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Date of last data collection
Anticipated
8/04/2019
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21057
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New Zealand
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State/province [1]
21057
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Otago
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Otago, Dunedin
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Address [1]
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School of Physical Education, Sport & Exercise Sciences, PO Box 56, Dunedin NZ 9054
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Country [1]
301219
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New Zealand
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Primary sponsor type
Individual
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Name
Assoc Prof Nancy Rehrer
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Address
University of Otago
School of Physical Education, Sport & Exercise Sciences, PO Box 56, Dunedin NZ 9054
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Country
New Zealand
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Secondary sponsor category [1]
300854
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Individual
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Name [1]
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Colleen Gulick
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Address [1]
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University of Otago
School of Physical Education, Sport & Exercise Sciences, PO Box 56, Dunedin NZ 9054
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Country [1]
300854
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New Zealand
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Other collaborator category [1]
280440
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Individual
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Name [1]
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Dr. Meredith Peddie
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Address [1]
280440
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Department of Human Nutrition, University of Otago
PO Box 56
Dunedin, NZ 9054
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Country [1]
280440
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
301964
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University of Otago
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Ethics committee address [1]
301964
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School of Physical Education, Sport & Exercise Sciences, PO Box 56, Dunedin NZ 9054
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Ethics committee country [1]
301964
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New Zealand
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Date submitted for ethics approval [1]
301964
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03/12/2018
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Approval date [1]
301964
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Ethics approval number [1]
301964
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Summary
Brief summary
Hypotheses:
We hypothesize that dietary protein and exercise will both independently increase the acute Insulin Like Growth Factor-1 (IGF-1) response, but thereafter, exercise will reduce IGF-1 concentration in the rested, fasted state and the associated binding protein (IGFBP3) will decrease with exercise with and without protein .
This study will expand upon the current literature regarding the effects of dietary protein, exercise and the combination thereof on IGF-1 and IGFBP3. The knowledge gained from this study may inform public health messages concerning possible adverse health effects of consuming high amounts of protein, and any ameliorating effects of exercise. Knowledge of the time-course of responses will also aid future research to know when to sample for peak and nadir concentrations.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Nancy Rehrer
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Address
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School of Physical Education, Sport & Exercise Sciences
PO Box 56
Dunedin, NZ 9054
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Country
88690
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New Zealand
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Phone
88690
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+64 3 479 9128
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Fax
88690
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Email
88690
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[email protected]
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Contact person for public queries
Name
88691
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Miss Colleen Gulick
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Address
88691
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University of Otago
School of Physical Education, Sport & Exercise Sciences
PO Box 56
Dunedin, NZ 9054
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Country
88691
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New Zealand
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Phone
88691
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+64 210 393039
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Fax
88691
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Email
88691
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[email protected]
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Contact person for scientific queries
Name
88692
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Miss Colleen Gulick
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Address
88692
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University of Otago
School of Physical Education, Sport & Exercise Sciences
PO Box 56
Dunedin, NZ 9054
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Country
88692
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New Zealand
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Phone
88692
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+64 210393039
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Fax
88692
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Email
88692
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
unidentified participant data will be made available upon request for potential future meta-analyses
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When will data be available (start and end dates)?
immediately following publication, no end date
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Available to whom?
available to researchers that are conducting meta-analyses upon request
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Available for what types of analyses?
meta-analyses
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How or where can data be obtained?
provided by principal investigator on password protected device or by password protected mechanism
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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.
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