Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000757112
Ethics application status
Approved
Date submitted
14/05/2019
Date registered
22/05/2019
Date last updated
15/02/2021
Date data sharing statement initially provided
22/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intermittent fasting on muscle mass in overweight, middle-aged men
Scientific title
The effect of intermittent fasting on integrated muscle protein synthesis rates in overweight, middle-aged men
Secondary ID [1] 297936 0
Nil known
Universal Trial Number (UTN)
Trial acronym
IF-PRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
 312325 0
Sarcopenia 312832 0
Condition category
Condition code
Diet and Nutrition 310891 310891 0 0
Obesity
Musculoskeletal 311330 311330 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study design consists of a randomized, parallel-group intervention study in 40 overweight, middle-aged males. The study will involve a 3-day lead-in control diet for all intervention groups, after which subjects will be randomized to 10 consecutive days of either:
1. Alternate day fasting (ADF: 25 Energy percentage (En%) food ingestion on day 1, 3, 5, 7 and 100En% food ingestion on day 2, 4, 6, 8 and 10)
2. Continuous energy restriction (CER: daily intake of 62.5 En% of total energy intake)
3. Time restricted eating (TRE: daily intake of 100 En% of total energy intake in an 8 h time window)
4. An energy balanced control diet (CON: daily intake of 100 En% of total energy intake in a 12 h time window, according to current Australian Healthy Eating guidelines comprising a macronutrient intake of 50% En, CHO, 30% En fat and 20% En protein.).
A labelled water protocol will be used to determine changes in integrated muscle protein synthesis rates. Prior to and after the diet intervention, a test day will be performed to assess muscle metabolism, body composition, and glycemic control. All food will be provided to the participants and they will visit the university twice throughout the 10-day intervention to pick-up their meals. A registered dietitian will provide a personal diet to every participant based upon individualized energy requirements. Adherence to the diet will be conducted through a food log and continuous glucose monitoring for timing of meals.
Intervention code [1] 314159 0
Lifestyle
Intervention code [2] 314508 0
Behaviour
Comparator / control treatment
The control group will consume a standard diet according to current Australian Healthy Eating guidelines comprising a macronutrient intake of 50% of total energy intake as CHO, 30% of total energy intake as fat and 20% of total energy intake in protein .
Control group
Active

Outcomes
Primary outcome [1] 319711 0
The primary outcome measurement will be muscle protein synthesis rates (%/day) measured using the rate of labelled water (D2O) uptake from the muscle biopsy samples and alanine enrichments in saliva.
Timepoint [1] 319711 0
Day 0 and Day 11
Secondary outcome [1] 369263 0
Body composition assessed by a DEXA scan: total body mass (in % and kg)
Timepoint [1] 369263 0
Day 0, 4, 8 and 11
Secondary outcome [2] 370419 0
Glycemic control (Freestlye Libre continuous glucose monitoring)
Timepoint [2] 370419 0
Day 0 to Day 11 (15 minutes time intervals throughout the 10-day intervention period)
Secondary outcome [3] 370420 0
Body water 2H2O enrichment by GC-MS analyses
Timepoint [3] 370420 0
Muscle biopsies at Day 0 and Day 11; plasma samples at day 0,4,8 and 11; and daily saliva samples from Day 0-11
Secondary outcome [4] 370421 0
Plasma amino acid concentrations (total amino acid profile measured by LC-MS)
Timepoint [4] 370421 0
Day 0, 4, 8 and 11
Secondary outcome [5] 370422 0
Plasma gastrointestinal hormone concentrations (PYY, CCK, GLP, GIP and ghrelin)
Timepoint [5] 370422 0
Day 0, 4, 8 and 11
Secondary outcome [6] 370423 0
Plasma glucose concentrations in blood samples analysed by YSI 2900
Timepoint [6] 370423 0
Day 0, 4, 8 and 11
Secondary outcome [7] 370528 0
Plasma insulin concentrations (ELISA)
Timepoint [7] 370528 0
Day 0, 4, 8 and 11
Secondary outcome [8] 370616 0
Body composition assessed by a DEXA scan: fat free mass (in % and kg)
Timepoint [8] 370616 0
Day 0, 4, 8 and 11
Secondary outcome [9] 370617 0
Body composition assessed by a DEXA scan: fat mass (in % and kg)
Timepoint [9] 370617 0
Day 0, 4, 8 and 11
Secondary outcome [10] 370618 0
Free L-[2,3,3,3-2H4]-alanine muscle enrichments by GC-MS analyses
Timepoint [10] 370618 0
Muscle biopsies at Day 0 and Day 11
Secondary outcome [11] 370619 0
Free L-[2,3,3,3-2H4]-alanine plasma enrichments by GC-MS analyses
Timepoint [11] 370619 0
Plasma samples at day 0,4,8 and 11

Eligibility
Key inclusion criteria
- Male
- Age: 35-55 years
- BMI: 25-35 kg/m2
Minimum age
35 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current diagnosis of Type 2 Diabetes (HbA1C >6.5% or 48 mmol/mol)
2) Unable to attend the laboratory for visits and adhere to the 3-day lead-in diet and 10-day intervention diet
3) Currently meeting physical activity guidelines (i.e. doing more than 150 min of physical activity per week or >10,000 steps per day)
4) Major or chronic illness that impairs mobility or eating/digestion;
5) Previous bariatric surgery;
6) Shift workers;
7) Smoker (cigarette, e-cigarette or marijuana);
8) Individuals with strict dietary intake regimes (i.e. vegan, avoidance of principal study foods);
9) Individuals who are currently restricting their dietary intake (i.e. actively trying to diet and lose weight) or participating in regular fasting (defined as fasting >16 h/day or having completed twelve 24-h fasts within the past year);
10) Participating in shift work (i.e. >3 h between 22:00 h and 05:00 h for 1 day per week (>50 days per year))
11) Not weight stable (>5 kg body weight change over last 3 months);
12) Individuals who do not consume breakfast on at least 5 of 7 days per week (i.e. not eating regular meals);
13) On prescribed medications required to be taken with food in the early morning or late evening or taking other prescribed medications for <3 months.
14) On prescribed anti coagulation medications (interfering with muscle biopsy procedures)

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
A two-way with repeated measures analysis of variance (ANOVA) for Time (Pre to Post intervention) and Treatment (intervention) and Bonferroni post hoc will be used during data analysis of the primary and secondary outcomes over time. A one-way ANOVA will be done for parameters at only measured baseline (characteristics of the participants).

The statistical analyses and comparisons between intervention groups will be conducted based upon our hypothesis on the following intervention groups:
- Continuous energy restriction and alternate day fasting compared to the control diet
- Time restricted eating compared to the control diet

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2019
Actual
18/06/2019
Date of last participant enrolment
Anticipated
1/06/2020
Actual
16/03/2020
Date of last data collection
Anticipated
30/06/2020
Actual
16/03/2020
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302452 0
University
Name [1] 302452 0
Australian Catholic University
Country [1] 302452 0
Australia
Funding source category [2] 302772 0
Charities/Societies/Foundations
Name [2] 302772 0
The European Society for Clinical Nutrition and Metabolism
Country [2] 302772 0
Luxembourg
Primary sponsor type
University
Name
Australian Catholic University
Address
Faculty of Health Sciences
Centre for Exercise & Nutrition Research Program
Australian Catholic University
Level 5, 215 Spring Street,
Melbourne VIC 3000
Australia
Country
Australia
Secondary sponsor category [1] 302353 0
None
Name [1] 302353 0
Address [1] 302353 0
Country [1] 302353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303121 0
ACU Human Research Ethics Committee
Ethics committee address [1] 303121 0
Ethics committee country [1] 303121 0
Australia
Date submitted for ethics approval [1] 303121 0
Approval date [1] 303121 0
26/03/2019
Ethics approval number [1] 303121 0
2018-291H

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

Contacts
Principal investigator
Name 92542 0
Prof John Hawley
Address 92542 0
Exercise and Nutrition Research Group
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne, VIC, 3000, Australia
Country 92542 0
Australia
Phone 92542 0
+61 3 9953 3552
Fax 92542 0
Email 92542 0
[email protected]
Contact person for public queries
Name 92543 0
Imre Kouw
Address 92543 0
Exercise and Nutrition Research Group
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne, VIC, 3000, Australia
Country 92543 0
Australia
Phone 92543 0
+61 3 9230 8161
Fax 92543 0
Email 92543 0
[email protected]
Contact person for scientific queries
Name 92544 0
Imre Kouw
Address 92544 0
Faculty of Health Sciences
Centre for Exercise & Nutrition Research Program
Australian Catholic University
Level 5, 215 Spring Street,
Melbourne VIC 3000
Australia
Country 92544 0
Australia
Phone 92544 0
+613 9230 8161
Fax 92544 0
Email 92544 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
Due to potential identifiable data and ethical reasons IPD will not be made available


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
EmbaseEight-hour time-restricted eating does not lower daily myofibrillar protein synthesis rates: A randomized control trial.2023https://dx.doi.org/10.1002/oby.23637
N.B. These documents automatically identified may not have been verified by the study sponsor.