Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000197437
Ethics application status
Approved
Date submitted
27/01/2016
Date registered
15/02/2016
Date last updated
9/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of whey protein and HMB (beta-hydroxy-beta-methylbutyrate) supplementation on muscle strength and muscle mass during resistance exercise training in healthy young males
Scientific title
Effects of whey protein and HMB (beta-hydroxy-beta-methylbutyrate) supplementation on muscle strength and muscle mass during resistance exercise training in healthy young males a: randomized, controlled, double-blind study
Secondary ID [1] 288115 0
None
Universal Trial Number (UTN)
U1111-1177-4560
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 297016 0
Condition category
Condition code
Musculoskeletal 297240 297240 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-administered oral whey protein with HMB (beta-hydroxy beta-methylbutyrate) supplementation (2 serves/day - 25g Whey/serve + 1.5g HMB/serve for 12 weeks)

To supervise adherence to this intervention, will have participants return empty supplement satchels weekly.

Researcher supervised resistance exercise training :

Phase 1: 3 sessions/week (Mondays, Wednesdays and Fridays) for weeks 1-8. Monday exercise routine: Squat, Bench Press, Deadlift, Pull Ups, Dips, Bent Over Row, Dumbbell Shoulder Press, Barbell Curl, Skull Crushers (3 sets per exercise, 8-12RM (75% of 1RM), 60sec rest between sets). Wednesday exercise routine: Squat, Bench Press, Deadlift (5 sets per exercise, 5 maximal intended velocity repetition, 180sec rest between sets). Friday exercise routine: Squat, Bench Press, Pull Ups, Dips, Bent Over Row, Dumbbell Shoulder Press, Barbell Curl, Skull Crushers (3 sets per exercise, 3-5RM, 240sec rest between sets). Sessions will last

Phase 2 (over-reaching): 6 sessions/week for weeks 9-10. Monday and Wednesday exercise routine: Squat, Bench Press, Deadlift, Pull Ups, Dips, Bent Over Row, Dumbbell Shoulder Press, Barbell Curl, Skull Crushers (3 sets per exercise, 8RM (75% of 1RM) on Monday and 12RM (65% of 1RM) on Wednesday, 60sec rest between sets. Tuesday and Thursday exercise routine: Leg Press, Bench Press, Military Press, Supinated Pull Ups, Dips, Bent Over Row, Dumbbell Shoulder Press, Hammer Curl, Close Grip Bench (3 sets per exercise, 8RM (75% of 1RM) on Tuesday and 12RM (65% of 1RM) on Thursday, 60 sec rest between sets. Friday exercise routine: Squat, Bench Press and Deadlift 1RM test, 3 Maximal attempts, 1RM load with 5min ret between sets. Saturday exercise routine: Wingate test (Cycloergometer 30sec peak power test).

Phase 3 (taper): 3 sessions/week (Monday, Wednesday, Friday) of low intensity exercise for weeks 11-12. Exercise routine during week 11: Monday Friday - Squat, Bench Press and Deadlifts (5 sets, 5 repetition using maximal intended velocity, 180 rest, 40-60% 1RM). Monday - Squat, Bench Press, Deadlift, Pull Ups, Dips, Bent Over Row, Dumbbell Shoulder Press, Barbell Curl, Skull Crushers (1 sets per exercise, 3-5RM, >90%1RM, 240sec rest between sets). Exercise routine during week 12: Monday - Squat, Bench Press, Deadlift, Pull Ups, Dips, Bent Over Row, Dumbbell Shoulder Press, Barbell Curl, Skull Crushers (1 sets per exercise, 3-5RM, >90%1RM, 240sec rest between sets). Wednesday - Squat, Bench Press and Deadlifts (5 sets, 5 repetition using maximal intended velocity, 180 rest, 40-60% 1RM). Friday exercise routine: Squat, Bench Press and Deadlift 1RM test, 3 Maximal attempts, 1RM load with 5min ret between sets.

Exercise sessions will be conducted individually, with each subject supervised by a research group member and will last 1-1.5h depending of the routine. Adherence will be monitored by register of attendance at scheduled sessions. Phone calls and text messages will be made to contact subjects that do not attend exercise sessions at scheduled times. If that is the case, the session will be re-schedule to another time on the same day.
Intervention code [1] 293438 0
Lifestyle
Intervention code [2] 293439 0
Prevention
Comparator / control treatment
Control group will receive the same training and whey protein content, but will be supplemented with 1.5g/serve of Leucine instead of HMB

(2 serves/day - 25g Whey/serve + 1.5g Leucine/serve for 12 weeks)

To supervise adherence to this intervention, will have participants return empty supplement satchels weekly.
Control group
Active

Outcomes
Primary outcome [1] 296841 0
Change in maximum muscle strength determined by 1 repetition maximum (1RM) testing. 1RM tests will be performed for Squats, Bench Press and Deadlifts. 3 maximal attempts will be performed with 5min rest between them. The highest load used for a complete repetition will be counted as 1RM.
Timepoint [1] 296841 0
at baseline, 4 weeks, 8 weeks, 10 weeks and end of intervention
Primary outcome [2] 296842 0
change in muscle fiber CSA (cross sectional area) determined by immunohistoflourescence in muscle biopsies samples
Timepoint [2] 296842 0
at baseline and at end of intervention (0 weeks and 12 weeks)
Primary outcome [3] 296843 0
change in body composition determined using DXA
Timepoint [3] 296843 0
at baseline, 4 weeks, 8 weeks, 10 weeks and end of intervention
Secondary outcome [1] 319534 0
Changes in muscle size, using ultrasound images.
Timepoint [1] 319534 0
at baseline, 4 weeks, 8 weeks, 9 weeks, 10 weeks and end of intervention
Secondary outcome [2] 319535 0
muscle power, determined by cycling test
Timepoint [2] 319535 0
at baseline, 4 weeks, 8 weeks, 9 weeks, 10 weeks and end of intervention
Secondary outcome [3] 319536 0
Changes in serum Creatine Kinase activity, a muscle damage marker. Will be assayed by commercial kit.
Timepoint [3] 319536 0
at baseline, 4 weeks, 8 weeks, 9 weeks, 10 weeks and end of intervention
Secondary outcome [4] 320293 0
Perceived recovery status (PRS) scale will be measured to assess subjective recovery during the training phases. The PRS scale consists of values between 0 and 10, with 0–2 being very poorly recovered with anticipated declines in performance, 4–6 being low to moderately recovered with expected similar performance, and 8–10 representing high perceived recovery with expected increases in performance.
Timepoint [4] 320293 0
at baseline, 4 weeks, 8 weeks, 9 weeks, 10 weeks and end of intervention
Secondary outcome [5] 323930 0
Subjective sleep duration will be assessed by a researcher formulated questionnaire, asking participants the hours of sleep they had before training sessions. The questionnaire will also ask participants the number of night-time awakenings, time to fall asleep and the number of naps.
Timepoint [5] 323930 0
These measures will be taken at baseline, week 4, week 8, week 9, week 10 and week 12.
Secondary outcome [6] 323931 0
Objective measures of sleep parameters (i.e. sleep duration and sleep onset latency) will be made using a wrist-worn activity-monitoring device (i.e., ActiGraph) at various time points through the resistance exercise protocol. The ActiGraph will be worn for 120 hours (5 days) during these time points.
Timepoint [6] 323931 0
These measures will be taken at baseline, week 4, week 8, week 9, week 10 and week 12.
Secondary outcome [7] 323932 0
In order to assess subjective sleep quality, participants will complete the Pittsburgh Sleep Quality Index at five-time points. The score on the PSQI separates individuals into "poor" or "good" sleepers.
Timepoint [7] 323932 0
These measures will be taken at baseline, week 4, week 8, week 9, week 10 and week 12.

Eligibility
Key inclusion criteria
1-Male
2-Aged 18-30 years old
3-Non-obese (Body mass index less than or equal to 30kg per square meter)
4-Non-smoker
5-Healthy based on questionnaire responses (see exclusion criteria)
6-Recreationally active (exercising ~2x/week) with some resistance training experience (no more than 2 times weekly) allowed.
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1-Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders–all ascertained through medical history screening questionnaires
2-Arthritic conditions
3-Individuals who consume any analgesic or anti-inflammatory drug(s),
prescription or non-prescription, chronically will be excluded
4-A history of neuromuscular complications
5-Individuals on any medications known to affect protein metabolism (i.e. corticosteroides, non-steroidal anti-inflammatories, or prescription strength acne medications).
6-Extensive history of RE training in the year prior to study entry.
7-Answer ‘yes’ to any question on the PAR-Q Screening questionnaire

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)
allocation involves contacting the holder of the allocation schedule who will not be involved in the screening of potential subjects
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomization with stratification based on lean body mass and strength
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Considering the 25% variability in the response of lean body mass gain to resistance training and statistical power (1-beta) > 0.7 for a = 0.05 using a repeated measures two-way-analysis of variance (ANOVA) (within-factor) or Student's t- test to compare two independent means, a minimum of 14 subjects per group in necessary. To account for the possibility of increased variability in the sample set and allowing for a potential 20% drop-out rate, a conservative number of 20 subjects per group was chosen.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 7412 0
Canada
State/province [1] 7412 0
Ontario

Funding & Sponsors
Funding source category [1] 292545 0
Government body
Name [1] 292545 0
Natural Sciences and Engineering Research Council of Canada (NSERC)
Country [1] 292545 0
Canada
Primary sponsor type
Individual
Name
Dr. Stuart Phillips
Address
Ivor Wynne Centre, Room E210
Department of Kinesiology
McMaster University
1280 Main Street West
Hamilton, ON L8S 4K1
Country
Canada
Secondary sponsor category [1] 291262 0
None
Name [1] 291262 0
Address [1] 291262 0
Country [1] 291262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294021 0
Hamilton Integrated Research Ethics Board
Ethics committee address [1] 294021 0
1280 Main Street West
HSC-3H9
Hamilton ON L8S 4K1
Ethics committee country [1] 294021 0
Canada
Date submitted for ethics approval [1] 294021 0
01/12/2015
Approval date [1] 294021 0
27/01/2016
Ethics approval number [1] 294021 0
2016-1127-GRA

Summary
Brief summary
This will be a double-blind randomized trial. The participants will be supplemented with one of two different nutritional supplements and be submitted to resistance exercise training for 12 weeks. Participants will consume Whey Protein (25g) + Leucine (1.5g) or Whey protein (25g) + HMB (1.5g) twice a day.

The primary purpose of this study is to:
1) Accurately evaluate the effect of Whey+HMB relative to Whey+Leucine in regards to muscle strength and size adaptation following resistance exercise training

The secondary purpose of this study is to:
1) Quantitative evaluation the potential effect of HMB supplementation with resistance exercise on muscle power, total body mass, body fat mass, blood biochemistry, and muscle fiber cross-sectional area, as well as qualitative soreness/recovery status

Hypothesis
1) We believe both groups will present the same changes during the training protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62106 0
Dr Stuart Phillips
Address 62106 0
Ivor Wynne Centre, Room E210
Department of Kinesiology
McMaster University
1280 Main Street West
Hamilton, ON L8S 4K1
Country 62106 0
Canada
Phone 62106 0
+1 905 525 9140 ext. 24465
Fax 62106 0
Email 62106 0
[email protected]
Contact person for public queries
Name 62107 0
Prof Stuart Phillips
Address 62107 0
Ivor Wynne Centre, Room E210
Department of Kinesiology
McMaster University
1280 Main Street West
Hamilton, ON L8S 4K1
Country 62107 0
Canada
Phone 62107 0
+1 905 525 9140 ext. 24465
Fax 62107 0
Email 62107 0
[email protected]
Contact person for scientific queries
Name 62108 0
Dr Stuart Phillips
Address 62108 0
Ivor Wynne Centre, Room E210
Department of Kinesiology
McMaster University
1280 Main Street West
Hamilton, ON L8S 4K1
Country 62108 0
Canada
Phone 62108 0
+1 905 525 9140 ext. 24465
Fax 62108 0
Email 62108 0
[email protected]

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

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