Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000920998
Ethics application status
Approved
Date submitted
22/07/2020
Date registered
17/09/2020
Date last updated
17/09/2020
Date data sharing statement initially provided
17/09/2020
Date results provided
17/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of 12 weeks of resistance training combined with 5:2 intermittent fasting or continuous energy restriction on body composition, strength, compliance and gut microbiome.
Scientific title
Comparing the effects of 12 weeks of resistance training combined with 5:2 intermittent fasting or continuous energy restriction on body composition, strength, compliance, metabolic health and gut microbiome in normal weight, overweight and obese adults.
Secondary ID [1] 301850 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Excess adiposity 318340 0
Loss of lean body mass 318341 0
Condition category
Condition code
Diet and Nutrition 316349 316349 0 0
Other diet and nutrition disorders
Diet and Nutrition 316350 316350 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were randomly assigned to 1 of 2 dietary groups:
1. 5:2 intermittent fasting - participants were required to consume 100% of their estimated energy requirements 5 days per week, and ~30% of estimated energy requirement on 2, non-consecutive, non-exercising days per week (fasting days). Fasting day intake consisted of protein shakes, protein soups (provided to participants) and raw/steamed vegetables or;
2. Continuous energy restriction - participants were required to consume ~80% of their estimated energy requirements each day.

Both groups aimed to consume >=1.4 grams of protein per kilogram of body weight per day on average.

Participants were provided with customised meal plans and dietary advice at the beginning of the study by an accredited practising dietitian. The consultation with the dietitian lasted approximately 30 minutes, however, as the dietitian was also responsible for supervising the resistance training sessions (detailed below), participants had consistent contact with the dietitian over the 12 week intervention (~twice per week).

In addition, all participants were asked to undertake 12 weeks of resistance training consisting of:
- 2 full body workout sessions per week last approximately 45 minutes supervised by a strength and conditioning coach and dietitian at Swinburne University's Hawthorn (Victoria) campus. These were conducted in groups consisting of <6 individuals at any one time, and consisted of exercises in a super-set format (one exercise followed immediately by another, followed by a break). The super-sets included push-ups and squats, rows and lunges, bicep curls and dips, or variations of these exercises tailored to the individual's ability. Once participants could complete 3 sets of 15 repetitions of any of these exercises, the variation was made more difficult or weight added and;
- 1 unsupervised full body aerobic/resistance training combination session per week lasting approximately 30 minutes, which consisted of timed super-sets of the following exercises: planks and mountain-climbers, crunches and burpees, side toe touches and hip bridges. Participants were encouraged to increase the time (from a base of 30 seconds for each exercise) once they could complete the exercise for that time period with good form (self-assessed).

While effort level was not formally assessed, participants were encouraged and motivated throughout their supervised workouts to ensure a high level of effort. The unsupervised sessions were not assessed for effort, and participants were required to self-motivate. Attendance was recorded at each session, and participants were asked each week whether or not they had completed their unsupervised training session.

Changes in whole body composition were measured by dual x-ray absorptiometry and local muscular changes in the non-dominant thigh were measured using muscle ultrasound and pQCT. Dietary intake was assessed utilising 3 day electronic food diaries at baseline, week 1, 6 and 12 of the intervention. Blood samples were taken from an antecubital vein at baseline and after the intervention to assess changes in blood cholesterol, high sensitivity CRP, blood glucose and insulin levels. Dietary compliance, as well as changes in hunger, mood and energy levels were measured using daily surveys. Changes in gut microbiome in response to each diet were measured using DNA sequencing of frozen faecal samples collected at baseline and at the end of the intervention.
Intervention code [1] 318144 0
Lifestyle
Intervention code [2] 318145 0
Behaviour
Comparator / control treatment
In this study, the continuous energy restriction group, which represents common practice, standard treatment for excess weight or adiposity acts as the comparator/control group.
Control group
Active

Outcomes
Primary outcome [1] 324517 0
Lean body mass changes as assessed by dual x-ray absorptiometry.
Timepoint [1] 324517 0
Baseline and post week 12.
Secondary outcome [1] 384852 0
Local changes in the thigh muscle of the non-dominant leg as measured by ultrasound and pQCT
Timepoint [1] 384852 0
Baseline and post week 12.
Secondary outcome [2] 384853 0
Changes in dietary intake (energy, protein, fat, carbohydrate), measured using an electronic application (Easy Diet Diary) on 3 non consecutive days, including 2 week days and 1 weekend day.
Timepoint [2] 384853 0
Baseline, week 1, week 6, week 12.
Secondary outcome [3] 384854 0
Changes in serum cholesterol (total cholesterol, LDL-cholesterol and HDL-cholesterol). This was measured by obtaining a fasting blood sample that was allowed to clot for greater than 20 minutes but less than 40 minutes before being centrifuged at 3000 RPM to separate the serum. This was then aliquoted and stored at -84 degrees Celcius before being transferred on dry ice to an external lab for analysis.
Timepoint [3] 384854 0
Baseline and post week 12.
Secondary outcome [4] 384855 0
Changes in serum high-sensitivity CRP. This was measured by obtaining a fasting blood sample that was allowed to clot for greater than 20 minutes but less than 40 minutes before being centrifuged at 3000 RPM to separate the serum. This was then aliquoted and stored at -84 degrees Celcius before being transferred on dry ice to an external lab for analysis.
Timepoint [4] 384855 0
Baseline and post week 12.
Secondary outcome [5] 384856 0
Changes in serum glucose. This was measured by obtaining a fasting blood sample that was allowed to clot for greater than 20 minutes but less than 40 minutes before being centrifuged at 3000 RPM to separate the serum. This was then aliquoted and stored at -84 degrees Celcius before being transferred on dry ice to an external lab for analysis.
Timepoint [5] 384856 0
Baseline and post week 12.
Secondary outcome [6] 385888 0
Changes in serum insulin. This was measured by obtaining a fasting blood sample that was allowed to clot for greater than 20 minutes but less than 40 minutes before being centrifuged at 3000 RPM to separate the serum. This was then aliquoted and stored at -84 degrees Celcius before being transferred on dry ice to an external lab for analysis
Timepoint [6] 385888 0
Baseline and post week 12.
Secondary outcome [7] 385889 0
Changes in gut microbiome composition measured using DNA sequencing of frozen faecal samples.
Timepoint [7] 385889 0
Baseline and post week 12.
Secondary outcome [8] 385890 0
Dietary compliance.
-Each day participants were asked to rate their self-perceived compliance to the dietary protocol based on how close they felt they got to their prescribed energy and protein targets. They were asked to rate this on a 0-10 Likert scale.
Timepoint [8] 385890 0
This outcome was assessed daily, from week 1 of the intervention until the completion of week 12, with weekly averages used for analysis.
Secondary outcome [9] 385891 0
Changes in mood.
-Each day participants were asked to rate their mood using 4 questions:

How sad do you feel?
How tense do you feel?
How happy do you feel?
How calm do you feel?

These were rated on a 10 point Likert scale from 0-10, and adapted from a previously validated visual analogue scale for use on a mobile phone.
Timepoint [9] 385891 0
This outcome was assessed daily, from week 1 of the intervention until the completion of week 12, with weekly averages used for analysis.
Secondary outcome [10] 385892 0
Changes in hunger.
-Each day participants were asked to rate their hunger using 4 questions:

How hungry do you feel?
How satisfied do you feel?
How full do you feel?
How much do you think you can eat?

These were rated on a 10 point Likert scale from 0-10, and adapted from a previously validated visual analogue scale for use on a mobile phone.
Timepoint [10] 385892 0
This outcome was assessed daily, from week 1 of the intervention until the completion of week 12, with weekly averages used for analysis.
Secondary outcome [11] 385893 0
Changes in cravings.
-Each day participants were asked to rate their cravings using 4 questions:

Would you like something sweet?
Would you like something salty?
Would you like something savoury?
Would you like something fatty?

These were rated on a 10 point Likert scale from 0-10, and adapted from a previously validated visual analogue scale for use on a mobile phone.
Timepoint [11] 385893 0
This outcome was assessed daily, from week 1 of the intervention until the completion of week 12, with weekly averages used for analysis.
Secondary outcome [12] 385894 0
Changes in energy levels.
-Each day participants were asked to rate their mood using 4 questions:

How alert do you feel?
How much of an effort is it to do anything?
How weary do you feel?
How sleepy do you feel?

These were rated on a 10 point Likert scale from 0-10, and adapted from a previously validated visual analogue scale for use on a mobile phone.
Timepoint [12] 385894 0
This outcome was assessed daily, from week 1 of the intervention until the completion of week 12, with weekly averages used for analysis.

Eligibility
Key inclusion criteria
1. Aged between 18-45 years
2. BMI of 22.0-35.0
3. Body fat percentage >18% for males and >25% for females as assessed by dual x-ray absorptiometry
4. No structured resistance training program in the previous 6 months
5. Weight stable for 3 months prior to the study (<5% weight loss or weight gain)
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Smokers
2. Have diabetes
3. Have a history of cardiovascular disease
4. Are taking dietary supplements and unwilling to cease for the duration of the study
5. Taking glucose, blood lipid lowering or weight loss medication.
6. Have a current physical condition that could be exacerbated by resistance training (as determined by GP).
7. Are pregnant/intend to become pregnant during the course of the study
8. Are menopausal/post-menopausal
9. Have a history of disordered eating
10. Have a current or previous respiratory condition likely to be exacerbated by the intervention
11. Have a current or previous gastrointestinal disorder likely to be exacerbated by the intervention
12. Have an allergy to any components of the provided supplement
13. Were unable to commit to fasting if in the 5:2 intermittent fasting group
14. Do not speak English at a level with which they are able to understand and complete the requirements of the study or
14. Any other disclosed chronic disease or condition, or taking any other medication that investigators deem would contraindicate the study intervention.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation occurred by coin toss after participants were recruited and stratified based on sex, BMI and age.
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
Linear mixed models with time as a repeated measure will be used to analyse primary and secondary outcomes. Bivariate analysis will be used to identify correlations between variables with our primary outcome (lean body mass). Baseline characteristics will be compared between groups utilising non-paired t-tests. Descriptive analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/02/2019
Date of last participant enrolment
Anticipated
Actual
29/07/2019
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
51
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306274 0
University
Name [1] 306274 0
Swinburne University of Technology
Country [1] 306274 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Faculty of Health, Arts and Design
John Street, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 306765 0
None
Name [1] 306765 0
Address [1] 306765 0
Country [1] 306765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306481 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 306481 0
Ethics committee country [1] 306481 0
Australia
Date submitted for ethics approval [1] 306481 0
30/09/2018
Approval date [1] 306481 0
28/11/2018
Ethics approval number [1] 306481 0
#2018/322

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

Contacts
Principal investigator
Name 104042 0
A/Prof Regina Belski
Address 104042 0
Swinburne University of Technology
John Street, Hawthorn, Victoria, 3122
Country 104042 0
Australia
Phone 104042 0
+61 3 9214 4354
Fax 104042 0
Email 104042 0
[email protected]
Contact person for public queries
Name 104043 0
Stephen Keenan
Address 104043 0
Swinburne University of Technology
John Street, Hawthorn, Victoria, 3122
Country 104043 0
Australia
Phone 104043 0
+61 3 9214 8000
Fax 104043 0
Email 104043 0
[email protected]
Contact person for scientific queries
Name 104044 0
Stephen Keenan
Address 104044 0
Swinburne University of Technology
John Street, Hawthorn, Victoria, 3122
Country 104044 0
Australia
Phone 104044 0
+61 3 9214 8000
Fax 104044 0
Email 104044 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
For ethical reasons this will not be available due to potentially identifiable personal data.


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
SourceTitleYear of PublicationDOI
EmbaseIntermittent fasting and continuous energy restriction result in similar changes in body composition and muscle strength when combined with a 12 week resistance training program.2022https://dx.doi.org/10.1007/s00394-022-02804-3
EmbaseThe Effects of Intermittent Fasting and Continuous Energy Restriction with Exercise on Cardiometabolic Biomarkers, Dietary Compliance, and Perceived Hunger and Mood: Secondary Outcomes of a Randomised, Controlled Trial.2022https://dx.doi.org/10.3390/nu14153071
N.B. These documents automatically identified may not have been verified by the study sponsor.