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Trial registered on ANZCTR


Registration number
ACTRN12614000396628
Ethics application status
Approved
Date submitted
1/04/2014
Date registered
10/04/2014
Date last updated
4/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Is two days of intermittent fasting per week a feasible weight loss approach in obese male war veterans? A pilot study.
Scientific title
For obese male war veterans aged between 55-75 years, will two days of intermittent fasting per week when compared with a standard 500kcal reduced diet promote more weight loss.
Secondary ID [1] 284376 0
Nil known
Universal Trial Number (UTN)
U1111-1155-1826
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 291543 0
Condition category
Condition code
Diet and Nutrition 291922 291922 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intermittent Fasting Group
Participants will be asked to follow a diet containing only 500kcal for two non-consecutive days per week and eat normally (unrestricted but encouraged to follow healthy eating guidelines) on the other five days for 6 months. Participants will be taught how to count calories and recieve dietary advice regarding healthy eating and food portions (as per Australian Guide to Healthy Guidelines). A calorie counting book will be provided. They will receive regular dietetic review and monitoring during the first 3 months (baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks) and minimal contact during the remaining 3 months. The initial session with the dietitian at baseline will be 45 minutes in duration and all subsequent reviews will be 30 minutes in duration. Participants will have biochemical markers (fasting lipids and fasting glucose), biological impedence (to estimate percentage body fat), waist circumference and blood pressure taken at baseline, 3 months and 6 months. They will also complete a food frequency questionnaire and a validated quality of life questionnaire (AQoL 8D scale) at these times. Participants will have weight monitored and will be questioned about their compliance with the diet at all reviews (baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months). In order to promote compliance, participants will be provided with sample recipes and will be able to contact the study dietitian during business hours for further clarification or dietary advice.
Intervention code [1] 289105 0
Treatment: Other
Intervention code [2] 289159 0
Lifestyle
Comparator / control treatment
Standard Treatment (Standard Calorie Restricted Group)
Participants will be asked to follow a diet approximately 500kcal less than energy requirements every day for 6 months. Participants will recieve dietary advice regarding healthy eating and food portions (as per Australian Guide to Healthy Guidelines) to achieve this. They will receive regular dietetic review and monitoring during the first 3 months (baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks) and minimal contact during the remaining 3 months. Participants will have biochemical markers (fasting lipids and fasting glucose), biological impedence (to estimate percentage body fat), waist circumference and blood pressure taken at baseline, 3 months and 6 months. They will also complete a food frequency questionnaire and a validated quality of life questionnaire (AQoL 8D scale) at these times. Participants will have weight monitored and will be questioned about their compliance with the diet at all reviews (baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months). In order to promote compliance, participants will be provided with sample recipes and will be able to contact the study dietitian during business hours for further clarification or dietary advice.
Control group
Active

Outcomes
Primary outcome [1] 291828 0
Percentage weight loss. Weight will be measured on the same scales and scales will be calibrated prior to the trial commencing.
Timepoint [1] 291828 0
Baseline and at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 6 months after intervention commencement
Secondary outcome [1] 307628 0
Total cholesterol (fasting) as assessed by testing collected blood
Timepoint [1] 307628 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [2] 307629 0
LDL cholesterol (fasting) as assessed by testing collected blood
Timepoint [2] 307629 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [3] 307630 0
HDL cholesterol (fasting) as assessed by testing collected blood
Timepoint [3] 307630 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [4] 307631 0
Tryglycerides (fasting) as assessed by testing collected blood
Timepoint [4] 307631 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [5] 307632 0
Fasting glucose as assessed by testing collected blood
Timepoint [5] 307632 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [6] 307633 0
Waist circumference (cm) as assessed by using a standard measuring tape
Timepoint [6] 307633 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [7] 307634 0
Percentage body fat as assessed using biological impedence machine
Timepoint [7] 307634 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [8] 307635 0
Quality of life as assessed by using an AQoL 8D scale
Timepoint [8] 307635 0
Baseline and at 3 months and 6 months after intervention commencement
Secondary outcome [9] 307636 0
Food intake as assessed by completion of food frequency questionnaire (DQES)
Timepoint [9] 307636 0
Baseline and at 3 months and 6 months after intervention commencement

Eligibility
Key inclusion criteria
Male war veteran aged 55-75 years old
Have a BMI greater than or equal to 30kg/m2
Have a stable body weight (+/- 5% body weight change in the last 3 months)
Have own local doctor who is aware of the health issues of the participant
Minimum age
55 Years
Maximum age
75 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Have a medical contraindication (e.g. active cancer, unstable diabetes, insulin dependent diabetes, end stage renal failure)
Have a high alcohol intake (greater than 28 standard drinks per week)
Are taking antpsychotic medication associated with weight gain (Mirtazapine, Olanzapine, Clozapine)

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 Concealment
A simple randomisation protocol will be used to allocate participants to one of two dietary
intervention groups; the Intermittent Fasting Group (IFG) or the Standard Calorie Restricted
Group (SCRG). Numbered tokens representing
the total number of participants (i.e. numbered from 1-30) will be placed in an envelope. Once a participant has been recruited, an offsite administrator will then be asked to pull out a token for the participant and inform the principal investigator. The offsite administrator will not be told what the numbers represent and is not involved in any other aspect of the trial. Participants who are drawn an odd
number will be allocated to Intermittent Fasting Group (IFG) and participants who are
drawn an even number will be allocated to the Standard Calorie Restricted Group (SCRG).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Numbered tokens representing
the total number of participants (i.e. numbered from 1-30) will be placed in an envelope. Once a participant has been recruited, an offsite administrator will then be asked to pull out a token for the participant and inform the principal investigator. The offsite administrator will not be told what the numbers represent and is not involved in any other aspect of the trial. Participants who are drawn an odd
number will be allocated to one group and those drawn an even number will be allocated to the other group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is a pilot study so sample size calculations were not performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2288 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 7967 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 289016 0
Charities/Societies/Foundations
Name [1] 289016 0
Austin Medical Research Foundation
Address [1] 289016 0
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria
Australia 3084

Country [1] 289016 0
Australia
Funding source category [2] 289017 0
Charities/Societies/Foundations
Name [2] 289017 0
Dietitians Association of Australia
Address [2] 289017 0
1/8 Phipps Close
DEAKIN
ACT 2600

Country [2] 289017 0
Australia
Primary sponsor type
Individual
Name
Lauren Le Fevre
Address
Heidelberg Reaptriation Hospital
300 Waterdale Road
PO Box 5444
Heidelberg West
Victoria 3081
Country
Australia
Secondary sponsor category [1] 287693 0
Individual
Name [1] 287693 0
Marguerite Conley
Address [1] 287693 0
Heidelberg Repatriation Hospital
300 Waterdale Road
PO Box 5444
Heidelberg West
Victoria 3081
Country [1] 287693 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290823 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 290823 0
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria
Australia 3084

Ethics committee country [1] 290823 0
Australia
Date submitted for ethics approval [1] 290823 0
24/01/2014
Approval date [1] 290823 0
02/04/2014
Ethics approval number [1] 290823 0
HREC/14/Austin/33

Summary
Brief summary
This pilot study aims to determine whether the intermittent fasting approach leads to greater weight loss and greater improvements in blood sugar, cholesterol and blood pressure than a standard low energy diet in obese male war veterans. Our primary objective is to determine whether obese, male war veterans who undertake intermittent fasting (5:2 method) achieve at least 5% weight loss in six months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47434 0
Mrs Lauren Le Fevre
Address 47434 0
Heidelberg Repatriation Hospital
300 Waterdale Road
PO Box 5444
Heidelberg West
Victoria 3081
Country 47434 0
Australia
Phone 47434 0
+61394965011
Fax 47434 0
Email 47434 0
lauren.lefevre@austin.org.au
Contact person for public queries
Name 47435 0
Ms Marguerite Conley
Address 47435 0
Heidelberg Repatriation Hospital
300 Waterdale Road
PO Box 5444
Heidelberg West
Victoria 3081
Country 47435 0
Australia
Phone 47435 0
+61394965011
Fax 47435 0
Email 47435 0
margie.conley@austin.org.au
Contact person for scientific queries
Name 47436 0
Ms Marguerite Conley
Address 47436 0
Heidelberg Repatriation Hospital
300 Waterdale Road
PO Box 5444
Heidelberg West
Victoria 3081
Country 47436 0
Australia
Phone 47436 0
+61394965011
Fax 47436 0
Email 47436 0
margie.conley@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary