Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001062415
Ethics application status
Approved
Date submitted
22/06/2016
Date registered
9/08/2016
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of high energy diet on thoracic fat energy expenditure in lean and obese men.
Scientific title
The effect of high energy diet on thoracic fat energy expenditure in lean and obese men.
Secondary ID [1] 289521 0
NA
Universal Trial Number (UTN)
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 299229 0
Condition category
Condition code
Diet and Nutrition 299237 299237 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment diet is a 1 wk diet Intervention in lean and obese individuals. This diet will contain double the energy content of the control weight maintenance diet. All food will be given to participants by the researchers, which they will take home to eat unsupervised. The composition of this diet will be made up of whole foods identical to the control diet, with the additional energy to be provided primarily by high energy liquid meal replacements such as Sustagen, protein supplement beverages and flavoured milk. Participants will be free to eat and drink allocated for for a given day at any time they please, They will simply be asked to ensure they eat all of the food provided to them. All food will be provided to participants to be consumed in place of their regular diets. Food diaries will be provided to participants and they will be asked to record all food eaten including any additional food/drinks they consume. Water can be consumed ad libitum.

Washout between control and treatment diets will be three weeks.
Intervention code [1] 295113 0
Lifestyle
Comparator / control treatment
Details for the control diet are identical to the treatment diet except the total energy will be based on published equations (1) where the aim is to maintain stable weight. This equation to determine basal energy expenditure is based on calculating sleeping energy expenditure, multiplied by an activity factor (1.375);

sleeping energy expenditure = 47.3+4.05(fat free mass) + 1.12 (fat mass)

with fat and fat-free mass determined by DEXA imaging.

(1) Klausen et al, Am J Clin Nut 1997. Age and sex effects on energy expenditure. 65(4):895-907
Control group
Active

Outcomes
Primary outcome [1] 298720 0
Glucose uptake in upper thoracic fat is the primary outcome measure. It will be determined the day after completion of each diet using fluorodeoxyglucose positron emission tomography-computerised tomography (FDG PET-CT).
Timepoint [1] 298720 0
Glucose uptake in upper thoracic fat will be measured the day after each intervention diet period (both control and treatment diets)
Secondary outcome [1] 325045 0
whole body energy expenditure via indirect calorimetry.
Timepoint [1] 325045 0
energy expenditure will be measured the day after each intervention diet period (both control and treatment diets)

Eligibility
Key inclusion criteria
Males aged 18 – 35 years
Unmedicated
No major illness
Lean group: BMI less than 25 kg/m2
Obese group: BMI 30-40 kg/m2
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to give informed consent
females
Smokers
Regular continuous exercise of >2 hours and/or 4 days per week of moderate or greater intensity.
Claustrophobia
Vegetarians/vegans
Those with lactose intolerance
Individuals who have been exposed to radiation in the last 5 years for research purposes (excluding DEXA scanning)
Individuals with food allergies such as nut or dairy allergies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who is a membver of the research group but not involved in the study and located at a site other than the clinical research laboratories where the trial will be conducted
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis of the primary endpoint will be determined using a non-parametric Mann-Whitney U test comparing upper thoracic fat glucose uptake between diets because these data are always not normally distributed.

Power analysis
The primary outcome variable will be compared within individuals after the two diets in both the lean and obese groups. Power calculations are based on glucose uptake in upper thoracic fat; we have previously determined the standard deviation of the difference (SDD) after a chronic intervention in lean participants to be 19%. We have determined that a 10% change would be clinically and biologically meaningful and determined that 30 participants per group (Power 80%, a=0.05) would be required to detect this magnitude of difference.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
1/11/2018
Actual
Date of last data collection
Anticipated
18/12/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13434 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 293897 0
Other
Name [1] 293897 0
Baker IDI Heart and Diabetes Institute
Country [1] 293897 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Rd, Melbourne
Victoria, 3004
Country
Australia
Secondary sponsor category [1] 292722 0
None
Name [1] 292722 0
Address [1] 292722 0
Country [1] 292722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295315 0
The Alfred HEC
Ethics committee address [1] 295315 0
Ethics committee country [1] 295315 0
Australia
Date submitted for ethics approval [1] 295315 0
03/08/2016
Approval date [1] 295315 0
26/09/2016
Ethics approval number [1] 295315 0

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

Contacts
Principal investigator
Name 66850 0
Dr Andrew Carey
Address 66850 0
Baker IDI Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic 3004
Country 66850 0
Australia
Phone 66850 0
+61 3 8532 1251
Fax 66850 0
Email 66850 0
[email protected]
Contact person for public queries
Name 66851 0
Andrew Carey
Address 66851 0
Baker IDI Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic 3004
Country 66851 0
Australia
Phone 66851 0
+61 3 8532 1251
Fax 66851 0
Email 66851 0
[email protected]
Contact person for scientific queries
Name 66852 0
Andrew Carey
Address 66852 0
Baker IDI Heart and Diabetes Institute
PO Box 6492
Melbourne, Vic 3004
Country 66852 0
Australia
Phone 66852 0
+61 3 8532 1251
Fax 66852 0
Email 66852 0
[email protected]

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


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.