Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000988550
Ethics application status
Approved
Date submitted
9/09/2015
Date registered
22/09/2015
Date last updated
29/11/2019
Date data sharing statement initially provided
29/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of High-Fat Availability on Muscle Growth Responses to Exercise and Nutrition.
Scientific title
Increasing Free Fatty Acid Availability: Effects on Exercise- and Protein Feeding-Induced Muscle Protein Synthesis in Middle-Aged Overweight Males.
Secondary ID [1] 287433 0
Nil known
Universal Trial Number (UTN)
U1111-1174-1139
Trial acronym
INTRALIPID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 296148 0
Obesity 296149 0
Condition category
Condition code
Diet and Nutrition 296423 296423 0 0
Obesity
Musculoskeletal 296498 296498 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
36 participants will be recruited for this study. There will be 3 experimental groups to which participants will be randomly and equally assigned:

Group 1: Control Trial
The control group will be administered a constant infusion of saline (400 mL 0.9% saline) for 4 hours prior to consuming a 500 mL (total) of a protein beverage (~30 g of whey protein).

Group 2: Lipid (Fat) Emulsion Trial
The lipid emulsion group will be administered a constant infusion of lipid (fat) emulsion (400 mL 20% intralipid) for 4 hours prior to consuming a 500 mL (total) of a protein beverage (~30 g of whey protein).

Group 3: Exercise Trial
Participants in the exercise trial will be administered a constant infusion of lipid (fat) emulsion (400 mL 20% intralipid) for 4 hours. During the first hour of this infusion, participants will undertake a non-strenuous exercise session consisting of 30 minutes cycling at 50% of aerobic capacity. Participants will then complete a resistance exercise session consisting of an appropriate warm-up and then 6 sets of 10 repetitions at 75% of pre-determined maximum strength level of leg extension. At the end of the 4 hour infusion, participants will consume a 500 mL (total) protein beverage (~30 g whey protein) exactly the same as in the control trial.

Participants in each of the three groups will then rest throughout a 4 h recovery period during which additional skeletal muscle biopsies will be obtained at 2 hours and 4 hours following the ingestion of the protein drink.
Intervention code [1] 292798 0
Treatment: Other
Intervention code [2] 292799 0
Prevention
Intervention code [3] 292800 0
Lifestyle
Comparator / control treatment
Group 1: Control Trial
The control group will be administered a constant infusion of saline for 4 hours prior to consuming a 500 mL (total) of a protein beverage. The proteins to be ingested are found in whole foods of a normal diet, and have been shown previously to increase muscle growth.
Control group
Active

Outcomes
Primary outcome [1] 296053 0
Muscle Protein Synthesis (MPS)
Timepoint [1] 296053 0
Measured, via the infusion of a stable (non-radioactive) isotopic amino acid tracer, upon termination of the intralipid infusion and 2 and 4 hours following the ingestion of protein in all trials. Determination of MPS requires muscle biopsy sampling at the aforementioned time points; hence, 4 h after the intralipid (or saline) infusion commences and 2 and 4 h following the ingestion of the protein drink.
Primary outcome [2] 296054 0
Circulating free fatty acids
Timepoint [2] 296054 0
Measured in plasma at rest, 1 h following the start of the intralipd (or saline) infusion and every 20 min until the first muscle biopsy and subsequent ingestion of protein. Plasma will then be acquired every 15 min for the first our following protein ingestion and every 30 min thereafter until 4 h post-protein ingestion.
Secondary outcome [1] 317361 0
Cell signaling protein expression determined by initial processing (i.e., homogenization in appropriate buffers) of skeletal muscle (~30 mg) samples and subsequent Western blot analysis. In brief, homogenized samples will be boiled in Laemlli's sample buffer and then run, by electrophoresis, on pre-cast (Bio-Rad) criterion gels, transferred to PVDF membranes, and proteins immunodetected by probing a target antigen with the corresponding, commercially available (e.g., Abcam, Cell Signaling) antibody.
Timepoint [1] 317361 0
Determination of cell signaling protein expression requires muscle biopsy sampling which are to be collected at the end of the 4 h intralipid (or saline) infusion and then 2 and 4 h following the ingestion of the protein drink.
Secondary outcome [2] 317560 0
Gene expression will be determined by reverse-transcribing RNA extracted from skeletal muscle (~15 mg) samples, generation of a cDNA template and measurement of gene expression (i.e., mRNA transcript abundance) by the PCR technique.
Timepoint [2] 317560 0
Determination of gene expression requires muscle biopsy sampling which are to be collected at the end of the 4 h intralipid (or saline) infusion and then 2 and 4 h following the ingestion of the protein drink.

Eligibility
Key inclusion criteria
Male, physically inactive subjects who are overweight, i.e., a BMI of 27-32 kg/m2 but otherwise apparently healthy. Physically inactive is defined by less than 150 min of moderate-to-vigorous physical activity per week.
Minimum age
35 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Physically active, type II diabetics, insulin resistant, alcoholics or smokers.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will be initially stratified by age (35-39, 40-45, 46-49, 50-55). Subsequently, simple randomisation by roll of dice within the stratified segregation will be used to allocate individuals to each of the 3 groups. This will ensure that an equal number of subjects from each category of age will be allocated to a treatment group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2015
Actual
30/06/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292008 0
Government body
Name [1] 292008 0
Collaborative Research Network Grant
Country [1] 292008 0
Australia
Primary sponsor type
Individual
Name
Prof John Hawley
Address
Exercise Nutrition Research Group
School of Exercise Science
Level 1, Room 32, Daniel Mannix Building
Australian Catholic University
8-18 Brunswick St, Fitzroy
Victoria 3065
Country
Australia
Secondary sponsor category [1] 290676 0
Individual
Name [1] 290676 0
Dr Donny Camera
Address [1] 290676 0
Exercise Nutrition Research Group
School of Exercise Science
Level 1, Room 7, Daniel Mannix Building
Australian Catholic University
8-18 Brunswick St, Fitzroy
Victoria 3065
Country [1] 290676 0
Australia
Other collaborator category [1] 278618 0
Individual
Name [1] 278618 0
Mr William Smiles
Address [1] 278618 0
Exercise Nutrition Research Group
School of Exercise Science
Level 1, Daniel Mannix Building
Australian Catholic University
8-18 Brunswick St, Fitzroy
Victoria 3065
Country [1] 278618 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293499 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 293499 0
Ethics committee country [1] 293499 0
Australia
Date submitted for ethics approval [1] 293499 0
Approval date [1] 293499 0
27/08/2015
Ethics approval number [1] 293499 0
HREC-A 042/14

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

Contacts
Principal investigator
Name 60150 0
Prof John Hawley
Address 60150 0
Australian Catholic University
Level 1, Room 32, Daniel Mannix Building
8-18 Brunswick St, Fitzroy, Melbourne, VIC 3065
Country 60150 0
Australia
Phone 60150 0
+61-3-9953 3552
Fax 60150 0
Email 60150 0
[email protected]
Contact person for public queries
Name 60151 0
John Hawley
Address 60151 0
Australian Catholic University
Level 1, Room 32, Daniel Mannix Building
8-18 Brunswick St, Fitzroy, Melbourne, VIC 3065
Country 60151 0
Australia
Phone 60151 0
+61-3-9953 3552
Fax 60151 0
Email 60151 0
[email protected]
Contact person for scientific queries
Name 60152 0
John Hawley
Address 60152 0
Australian Catholic University
Level 1, Room 32, Daniel Mannix Building
8-18 Brunswick St, Fitzroy, Melbourne, VIC 3065
Country 60152 0
Australia
Phone 60152 0
+61-3-9953 3552
Fax 60152 0
Email 60152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidential


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.