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Trial registered on ANZCTR
Registration number
ACTRN12613001044718
Ethics application status
Approved
Date submitted
27/08/2013
Date registered
19/09/2013
Date last updated
19/09/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of resistance exercise and increasing doses of protein ingestion on muscle protein synthesis during acute energy deprivation
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Scientific title
The effect of resistance exercise and increasing doses of protein ingestion on myofibrillar protein synthesis in young, healthy, trained males and females
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Secondary ID [1]
283022
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Nil known
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Universal Trial Number (UTN)
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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:
Muscle mass loss prevention
289854
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Condition category
Condition code
Musculoskeletal
290212
290212
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0
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Normal musculoskeletal and cartilage development and function
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Diet and Nutrition
290213
290213
0
0
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Other diet and nutrition disorders
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Metabolic and Endocrine
290214
290214
0
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
Trial B - Subjects will arrived after 5 days of controlled energy deficit diet (30 kcal/kg fat free mass (FFM) per day). All diets will be prepared by a specialized team and provided as pre-packaged meals, adherence to diet will be monitored via a check-list filled by participants. Tracer intravenous administration (L-ring-13C6 Phe) will start upon subject arrival and continue during 3 h for measurement of resting fractional synthetic rate (FSR) in calorie restriction diet intervention. Thereafter, subjects will undertake a resistance exercise bout (leg press, 6 sets, 8 reps, 80% 1 repetition maximum, 3 min rest between sets). In this trial subjects will ingest a 0 (placebo), 15 or 30 g of Whey Protein in liquied form (500 ml) immediately after the exercise and FSR will be measured between 1 and 4 h post exercise for determining the muscle anabolic response to resistance exercise after 5 days of a calorie restriction diet.
Trials C & D -Subjects will arrived after 5 days of controlled energy deficit diet (30 kcal/kg fat free mass (FFM) per day). Ring-13C6 Phe infusion will begin prior to resistance exercise. At the completion of exercise, subjects will ingest either 0 (placebo), 15 or 30 g of Whey Protein in liquid form (500 ml). FSR will be measured between 1 and 4 h post exercise for determining the response after exercise to either 0, 15 or 30g of WP after 5 days of a calorie restriction diet.
The difference between trial B and C & D is that trial B incorporates measurement of resting FSR prior to exercise, whereas trial C and D do not incorporate a period of resting FSR measurement. After exercise all the trials are essentially the same but the drinks will be randomized to contain either 0, 15 or 30 g of protein.
All participants will undertake all trials. The washout period between trials is 9 days.
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Intervention code [1]
287742
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Lifestyle
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Comparator / control treatment
Trial A – Subjects will arrive after 5 days of controlled energy balanced diet (45 kcal/kg FFM per day). All diets will be prepared by a specialized team and provided as pre-packaged meals, adherence to diet will be monitored via a check-list filled by participants. Tracer intravenous administration (L-ring-13C6 Phe) will start upon subject arrival and continue during 3 h for measurement of resting fractional synthetic rate (FSR) under energy balance. This trial incorporates no resistance exercise intervention or protein intake.
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Control group
Active
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Outcomes
Primary outcome [1]
290326
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myofibrillar fractional synthetic rate (FSR). Measured using primed constant intravenous infusion of ring-[13C6]phenylalanine. FSR is determined as the difference of tracer enrichment in myofibrillar protein between two subsequent skeletal muscle biopsies.
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Assessment method [1]
290326
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Timepoint [1]
290326
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Two muscle biopsies taken 3 h apart for each treatment. Resting energy balance (trial A) and energy deficit (trial B): 0 and 3 h after initiation of tracer infusion.
Exercise (trials B,C and D): 1 and 4 h after finalization of exercise/ingestion of protein or placebo drink.
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Secondary outcome [1]
304307
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Intracellular signalling measured through western blotting of cytoplasmic proteins using specific primary antibodies.
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Assessment method [1]
304307
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Timepoint [1]
304307
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Resting energy balance, 3 h; Resting energy deficit (ED), 3 h; ED + Resistance exercise (REX) + placebo (PL), 1 h; ED + REX + PL, 4 h; ED + REX + 15 g protein, 1 h; ED + REX + 15 g protein, 4 h; ED + REX + 30 g protein, 1 h; ED + REX + 30 g protein, 4 h.
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Secondary outcome [2]
304308
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mRNA content for specific genes, measured using real time PCR
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Assessment method [2]
304308
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Timepoint [2]
304308
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Resting energy balance, 3 h; Resting energy deficit (ED), 3 h; ED + Resistance exercise (REX) + placebo (PL), 1 h; ED + REX + PL, 4 h; ED + REX + 15 g protein, 1 h; ED + REX + 15 g protein, 4 h; ED + REX + 30 g protein, 1 h; ED + REX + 30 g protein, 4 h.
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Eligibility
Key inclusion criteria
All subjects must comply with the following inclusion criteria:
1) Healthy and physically active (as determined by medical and activity questionnaire)
2) Having given informed consent
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Minimum age
18
Years
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Maximum age
35
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
Subjects representing one or more of the following criteria are excluded from participation in the study.
1) Exhibiting health risk factors as identified on the health screening questionnaire
2) Having any identified metabolic or intestinal disorders
3) Tobacco use
4) Aspirin use in the four days prior to the experimental trial
5) Consumption of prescription medications or any performance enhancing agent
6) Inability to endure the strenuous exercise bouts e.g. injuries
7) Alcohol intake during the 48 hours prior to each of the testing days
8) Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
9) Have given blood in the last three weeks
10) Verbal confirmation that they have used a substance on the WADA banned list within the last year
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Study design
Purpose of the study
Treatment
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/05/2011
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Actual
23/05/2011
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Date of last participant enrolment
Anticipated
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Actual
15/08/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
16
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT
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Funding & Sponsors
Funding source category [1]
287843
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Government body
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Name [1]
287843
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Australian Research Council
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Address [1]
287843
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Level 2, 11 Lancaster Place
Majura Park ACT 2609
AUSTRALIA
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Country [1]
287843
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Australia
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Primary sponsor type
University
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Name
RMIT University
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Address
McKimmies and Plenty Rd
Bundoora 3083
Victoria
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Country
Australia
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Secondary sponsor category [1]
286571
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Government body
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Name [1]
286571
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Australian Institute of Sport
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Address [1]
286571
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Leverrier Crescent, Bruce ACT 2617, Australia
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Country [1]
286571
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Australia
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Our primary objective is to determine the effect of 5 days of dietary energy restriction (i.e. ~30 vs. the normal energy balance of ~45kcal/kg FFM/day) on muscle myofibrillar fractional synthetic rate (FSR; directly measured muscle protein synthesis) at rest as measured by primed constant infusion of ring-[13C6]phenylalanine.
Our secondary objectives involve examining whether the anabolic stimulus of protein ingestion and resistance exercise will significantly increase FSR (post-exercise FSR). If an exercise plus nutrition intervention rescues the deleterious effect of a hypocaloric diet on muscle FSR this will provide novel and practical information for effective weight management in which fat mass can be reduced without loss of muscle mass.
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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
42166
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Prof John A Hawley
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Address
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McKimmies and Plenty Rds
Building 203.3.32
RMIT University
Bundoora
Victoria 3083
AUSTRALIA
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Country
42166
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Australia
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Phone
42166
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61-3-9925 7353
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Fax
42166
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Email
42166
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[email protected]
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Contact person for public queries
Name
42167
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Prof John A Hawley
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Address
42167
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McKimmies and Plenty Rds
Building 203.3.32
RMIT University
Bundoora
Victoria 3083
AUSTRALIA
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Country
42167
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Australia
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Phone
42167
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61-3-9925 7353
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Fax
42167
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Email
42167
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[email protected]
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Contact person for scientific queries
Name
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Prof John A Hawley
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Address
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McKimmies and Plenty Rds
Building 203.3.32
RMIT University
Bundoora
Victoria 3083
AUSTRALIA
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Country
42168
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Australia
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Phone
42168
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61-3-9925 7353
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Fax
42168
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Email
42168
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[email protected]
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No information has been provided regarding IPD availability
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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