Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001062516
Ethics application status
Approved
Date submitted
16/09/2015
Date registered
12/10/2015
Date last updated
23/06/2021
Date data sharing statement initially provided
23/06/2021
Date results provided
23/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of consuming a high fat diet with and without undertaking resistance exercise on physical and psychological well-being
Scientific title
Can resistance exercise performed by middle-aged males ‘rescue’ the high fat diet-induced impairment in muscle protein synthesis?
Secondary ID [1] 287470 0
Nil
Universal Trial Number (UTN)
Trial acronym
FAT-ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia
 296202 0
Obesity 296203 0
Condition category
Condition code
Diet and Nutrition 296481 296481 0 0
Obesity
Musculoskeletal 296500 296500 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
16 participants will be recruited for this study. There will be 2 experimental groups to which participants will be randomly and equally assigned:

Group 1: High Fat Diet
Participants in Group 1 will consume a 9-day ‘high fat’ diet consisting of ~65% total energy as fat, ~20% total energy as carbohydrate and ~15% total energy as protein. This diet has been used multiple times previously by the research team and will be produced by the study dietitian in accordance with personal food preferences and any allergies. Participants will be provided all meals for this part of the study and will receive individual diet counselling by the study dietitian when required.

Group 2: High Fat Diet and Resistance Exercise
Participants in Group 2 will consume the identical diet as Group 1. In addition, on days 6, 9 and 12, participants will perform a lower-body resistance exercise session. For the resistance exercise, participants will perform 3 exercise in total: machine-based leg press and leg extension, and a free-weight dumbbell squat. All exercises (3-4 sets of 10-12 repetitions each exercise) will be performed at ~75% of the participants pre-determined 1 repetition maximum. The sessions will be conducted with the participants individually, or in groups of 2, of which will supervised by researchers that have obtained at least a Certificate III qualification in Exercise/Fitness Instruction.

In both groups, the initial control diet for days 1-3 is based on current Australian recommended daily intakes, and consists of ~20% total energy as fat, ~65% total energy as carbohydrate and ~15% total energy as protein..Diets will be prepared beforehand by a dietitian and participants will have all of their meals provided to them for the entire dietary period. The meals will be collected from the ACU School of Exercise Science at times arranged with study participants. Regular phone calls and a dietary recall will be used to monitor adherence to the diets. Participants in the resistance exercise group will be advised that all exercise sessions need to be attended in order to complete the study, of which there will be a total of 3 across a 7 day period.
Intervention code [1] 292850 0
Treatment: Other
Intervention code [2] 292851 0
Prevention
Intervention code [3] 292852 0
Lifestyle
Comparator / control treatment
Group 1: High Fat Diet
Participants in Group 1 will consume a 9-day ‘high fat’ diet consisting of ~65% total energy as fat, ~20% total energy as carbohydrate and ~15% total energy as protein. This group will serve as a control with respect to investigating the capacity for resistance exercise to potentially ameliorate the repressive effects of fat toward muscle growth responses.
Control group
Active

Outcomes
Primary outcome [1] 296107 0
Muscle Protein Synthesis (MPS)
Timepoint [1] 296107 0
MPS will be determined by the participants consuming doses of deuterium water (50 ml four times/ day for a total 200 ml/day) everyday throughout the nine day high fat intervention (total = 1.8 litres). Muscle biopsies will be acquired in order to analyse MPS responses and these will be taken on days 4, 6, 9 and 12 of the high fat dietary control period (Note: for days 1-3 participants will consume a standard carbohydrate-based diet as a 'lead in') to determine changes in protein synthesis before and after dietary modification and after resistance exercise. In addition, the determination of MPS via the deuterium method requires blood sampling, of which a single sample (~5 mL) will be taken on each day during dietary control (i.e., days 4-12).
Secondary outcome [1] 317528 0
Oral glucose tolerance test (OGTT)
Timepoint [1] 317528 0
Performed at baseline; hence, 10-12 days before dietary control.
Secondary outcome [2] 317569 0
A dual energy X-ray absorptiometry scan (DXA) for body composition. The DXA scan will measure total body mass, fat mass and lean mass.
Timepoint [2] 317569 0
Baseline; hence, 10-12 days prior to dietary control.
Secondary outcome [3] 317570 0
Cognitive Assessment Tasks involving questions and problem solving tasks designed to measure a range of cognitive functions including learning, memory, attention, decision making, verbal fluency and reaction times.

The specific, validated tests are as follows:
1. Cognitive functioning questionnaire
2. Wechsler Test of Adult Reading
3. Symbol Digit Modalities Test
4. California Verbal Learning Test (CVLT)
5. Taylor Figure Test
6. Verbal Fluency
7. Fatigue Severity Index
8. N-Back task
9. Iowa Gambling Task
10. Stop Signal Task
11. Colour Blind Question
12. Wisconsin Card Sorting Test
13. CVLT (delay)
14. Taylor Figure (delay)
Timepoint [3] 317570 0
Days 4, 7 and 12 of dietary control.

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 baseline BMI values. Subsequently, simple randomisation by roll of dice within the stratified segregation will be used to allocate individuals to each of the 2 groups. This will ensure that an equal number of subjects from each category of BMI will be allocated to an intervention 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
Actual
1/09/2015
Date of last participant enrolment
Anticipated
31/10/2015
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
30/11/2015
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292048 0
Government body
Name [1] 292048 0
Collaborative Research Network Grant
Country [1] 292048 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] 290716 0
Individual
Name [1] 290716 0
Dr Donny Camera
Address [1] 290716 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] 290716 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293529 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 293529 0
Ethics committee country [1] 293529 0
Australia
Date submitted for ethics approval [1] 293529 0
Approval date [1] 293529 0
03/08/2015
Ethics approval number [1] 293529 0

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

Contacts
Principal investigator
Name 60322 0
Prof John Hawley
Address 60322 0
Australian Catholic University
Level 1, Room 32, Daniel Mannix Building
8- 18 Brunswick St, Fitzroy, Melbourne, VIC 3065
Country 60322 0
Australia
Phone 60322 0
+61-3-9953 3552
Fax 60322 0
Email 60322 0
[email protected]
Contact person for public queries
Name 60323 0
John Hawley
Address 60323 0
Australian Catholic University
Level 1, Room 32, Daniel Mannix Building
8- 18 Brunswick St, Fitzroy, Melbourne, VIC 3065
Country 60323 0
Australia
Phone 60323 0
+61-3-9953 3552
Fax 60323 0
Email 60323 0
[email protected]
Contact person for scientific queries
Name 60324 0
Donny Camera
Address 60324 0
Australian Catholic University
Level 1, Daniel Mannix Building
8- 18 Brunswick St, Fitzroy, Melbourne, VIC 3065
Country 60324 0
Australia
Phone 60324 0
+61-3-9953 3557
Fax 60324 0
Email 60324 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.