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Trial registered on ANZCTR


Registration number
ACTRN12618000938202
Ethics application status
Approved
Date submitted
23/05/2018
Date registered
4/06/2018
Date last updated
22/01/2020
Date data sharing statement initially provided
26/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Time-restricted eating in individuals with type 2 diabetes
Scientific title
A time for food: The feasibility of time-restricted eating in individuals with type 2 diabetes and consequential effects on glycaemic control
Secondary ID [1] 294863 0
N/A
Universal Trial Number (UTN)
U1111-1213-9327
Trial acronym
T2RE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 307812 0
Overweight/obesity 307814 0
Condition category
Condition code
Diet and Nutrition 306860 306860 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 307082 307082 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to complete four weeks of time-restricted eating (TRE) where their energy intake (including caffeine but excluding water) is reduced to only between 10 am and 7 pm. To do this, participants will attend weekly meetings with the primary investigator, will use the Easy Diet Diary app to log their energy intake, or standard written food diaries, and will take photos with their smart phone to capture the time that they have eaten their meals (especially the first and last eating occasion; i.e. anything from dinner onwards will be photographed).
Adherence will be measured through the total eating duration over each weekday and weekend day, with participants encouraged to adhere to the 9 hour limit (i.e. 10 am to 7 pm) on as many days of the week as possible.
Intervention code [1] 301174 0
Behaviour
Comparator / control treatment
Participants will be followed over a two week "habitual" period, prior to the four week TRE period, where recordings of energy intake and the time of energy intake will be taken.
Control group
Active

Outcomes
Primary outcome [1] 305885 0
Feasibility: through the primary outcome of recruitment rate, retention rate, safety and adverse events, compliance to the TRE protocol and acceptability (attitudes/opinions/barriers). This will be assessed as a composite primary outcome as no one measure can assess for feasibility.
Recruitment rate will be assessed via the number of persons screened compared to final enrollments.
Retention rate will be assessed via the number of participants enrolled compared to the number of participants who finish the final study measures
Safety will be assessed using participant report of adverse events, i.e. self-report of any gastrointestinal, nausea, dizziness or other events as a result of the dietary intervention. As a clinical measure, the incidence of hypoglycaemia (i.e. time spent with blood glucose <3 mmol/L) from the continuous glucose monitors will be used to report the percentage of glucose values below 3 mmol/L and time below 3 mmol/L, as well as number of episodes (defined as at least 10 consecutive min below 3 mmol/L).
Compliance to the dietary intervention will be assessed using a combination of participant self-report and photo images of meal times (with time stamps).
Acceptability (attitudes/opinions/barriers) will be assessed in a qualitative questionnaire at the completion of the intervention (i.e. after 4 weeks of TRE)
Timepoint [1] 305885 0
Data for safety and adverse events, and compliance will be collected weekly (i.e. at the end of each week of TRE (weeks 2,3,4, and 5 of the total intervention period)).
At the completion of the study, once as many of the 24 participants that were assigned to complete four weeks of TRE have finished the four week period, recruitment and retention rates, and participant reports on acceptability will be collected.
Secondary outcome [1] 346888 0
Glucose control measured using continuous glucose monitors worn throughout the intervention period.
Timepoint [1] 346888 0
From the two week habitual period compared to the last two weeks of the TRE intervention. Further, comparisons across each week will be made.
Secondary outcome [2] 346910 0
Body mass and composition changes assessed using whole body DXA scans
Timepoint [2] 346910 0
Following habitual diet vs after 4 weeks of TRE
Secondary outcome [3] 346911 0
Fasting venous blood glucose
Timepoint [3] 346911 0
Measured after two weeks of habitual diet, as well as weekly throughout the four weeks of the TRE intervention. Comparisons between the habitual vs end of TRE intervention, as well as any changes across time during the four week TRE intervention.
Secondary outcome [4] 346912 0
Composite secondary outcome of dietary intake (total energy and macronutrient intake) and timing of energy intake
Dietary intake will be measured using self-report and analyses in Foodworks software; timing of energy intake will be assessed using time-stamped images of foods combined with self report timing of intake.
Timepoint [4] 346912 0
Measured throughout the two week habitual period compared to each week of the TRE intervention. Weekday vs weekend comparison. Compliant vs uncompliant days.
Secondary outcome [5] 347155 0
Physical activity patterns, using activPAL, ActiGraph and Sensewear monitors to determine the amount of time spent in the different domains of physical activity/sedentary behaviour
Timepoint [5] 347155 0
Assessed across the two week habitual period compared to each week (of four) of the TRE intervention
Secondary outcome [6] 347173 0
Composite outcome of self-reported appetite will be collected using visual analogue scales (score between 0 - 100)
Timepoint [6] 347173 0
Qualitative measures will be taken at the end of the habitual period and at the end of the four weeks of TRE.
Secondary outcome [7] 347176 0
Composite measure of self-reported daily sleep quality will be assessed using an abbreviated version of the Core Consensus Sleep Diary (Carney et al 2012) as well through the measure of sleep efficiency from the Sensewear armbands.
Timepoint [7] 347176 0
Sleep quality will be compared between the habitual period and across each of the four weeks of TRE through daily questionnaires.
Secondary outcome [8] 347224 0
Untargeted metabolomics on serum and stool samples using both high-resolution gas Chromotography mass Spectrometry and Liquid Chromatography Mass Spectrometry technologies.
Timepoint [8] 347224 0
From samples collected at the end of the habitual period, and at the end of each week of TRE (i.e. weeks 1, 2, 3 and 4) for a comparison across time.
Secondary outcome [9] 347225 0
Exploratory gut microbiome analyses
Timepoint [9] 347225 0
From stool samples collected during a 24 hour collection period at the end of the habitual period, and at the end of each week of TRE (i.e. weeks 1, 2, 3 and 4) for a comparison across time.
Secondary outcome [10] 347583 0
Self-reported fatigue will be collected using visual analogue scales (score between 0 - 100)
Timepoint [10] 347583 0
Qualitative measures will be taken at the end of the habitual period and at the end of the four weeks of TRE.
Secondary outcome [11] 347584 0
Sleep quantity will be calculated from sleep/wake times generated using the SenseWear Armband monitors
Timepoint [11] 347584 0
Sleep quantity will be compared between the habitual period and across each of the four weeks of TRE.
Secondary outcome [12] 347585 0
Assessment of Quality of Life (AQOL; Richardson, Iezzi, Khan, & Maxwell, 2014) from questionnaires
Timepoint [12] 347585 0
From questionnaires collected at the end of the habitual period, and at the end of TRE (i.e. week 4) for a comparison between habitual diet and following the TRE intervention.
Secondary outcome [13] 347586 0
Assessment of psychological distress using the Depression, Anxiety and Stress Scale (DASS; Lovibond & Lovibond, 1995)
Timepoint [13] 347586 0
From questionnaires collected at the end of the habitual week, and at the end of TRE (i.e. week 4) for a comparison between habitual diet and following the TRE intervention.
Secondary outcome [14] 347587 0
Assessment of disordered eating (using three factor eating questionnaire, Eating Disorders Examination Questionnaire (Fairburn & Beglin, 1994))
Timepoint [14] 347587 0
From questionnaires collected at the end of the habitual period, and at the end of TRE (i.e. week 4) for a comparison between habitual diet and following the TRE intervention.
Secondary outcome [15] 347588 0
Assessment of clinical impairment scale (CIS; (Bohn & Fairburn, 2008)) from a questionnaire
Timepoint [15] 347588 0
From questionnaires collected at the end of the habitual period, and at the end of TRE (i.e. week 4) for a comparison between habitual diet and following the TRE intervention.
Secondary outcome [16] 347589 0
Assessment of sleep quality using the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989)
Timepoint [16] 347589 0
From questionnaires collected at the end of the habitual period, and at the end of TRE (i.e. week 4) for a comparison between habitual diet and following the TRE intervention.
Secondary outcome [17] 347590 0
Assessment of cognition using the Cogstate online cognitive survey
Timepoint [17] 347590 0
From questionnaires collected at the end of the habitual period, and at the end of TRE (i.e. week 4) for a comparison between habitual diet and following the TRE intervention.
Secondary outcome [18] 347617 0
Fasting plasma insulin concentrations
Timepoint [18] 347617 0
Measured after two weeks of habitual diet, as well as weekly throughout the four weeks of the TRE intervention. Comparisons between the habitual vs end of TRE intervention, as well as any changes across time during the four week TRE intervention.
Secondary outcome [19] 347618 0
Fasting plasma ghrelin concentrations
Timepoint [19] 347618 0
Measured after two weeks of habitual diet, as well as weekly throughout the four weeks of the TRE intervention. Comparisons between the habitual vs end of TRE intervention, as well as any changes across time during the four week TRE intervention.
Secondary outcome [20] 347619 0
Fasting blood lipid concentrations
Timepoint [20] 347619 0
Measured after two weeks of habitual diet, as well as weekly throughout the four weeks of the TRE intervention. Comparisons between the habitual vs end of TRE intervention, as well as any changes across time during the four week TRE intervention.
Secondary outcome [21] 347620 0
Glucose and insulin concentration response (composite outcome) to a mixed meal tolerance test (MMTT)
Timepoint [21] 347620 0
Completed prior to the intervention (pre) and following four weeks of the TRE intervention (post), from samples collected at 0 (before) and 30, 60, 90 and 120 min post-MMTT consumption
Secondary outcome [22] 347621 0
Exploratory gut metabolome measures
Timepoint [22] 347621 0
From stool samples collected during a 24 hour collection period at the end of the habitual period, and at the end of each week of TRE (i.e. weeks 1, 2, 3 and 4) for a comparison across time.
Secondary outcome [23] 347622 0
Exploratory serum metabolome analyses
Timepoint [23] 347622 0
From plasma samples collected during a 24 hour collection period at the end of the habitual period, and at the end of each week of TRE (i.e. weeks 1, 2, 3 and 4) for a comparison across time.
Secondary outcome [24] 349383 0
Exploratory gut microbiome analyses
Timepoint [24] 349383 0
From stool samples collected during a 24 hour collection period at the end of the habitual period, and at the end of each week of TRE (i.e. weeks 1, 2, 3 and 4) for a comparison across time.
Secondary outcome [25] 349384 0
Assessment of nutrition quality of life (NQOL) using the NQOL survey (Barr & Schumacher, 2003)
Timepoint [25] 349384 0
From questionnaires collected at the end of the habitual period, and at the end of TRE (i.e. week 4) for a comparison between habitual diet and following the TRE intervention.

Eligibility
Key inclusion criteria
• Aged 35 to 65 years old
• Diagnosed (by a GP/endocrinologist) with type 2 diabetes mellitus (T2D), with an HbA1c between 6.5% - 9%, either with diet-controlled or taking up to two oral hypoglycaemic agents (excluding sulphonylureas)
• Body mass index (BMI) between 25 - 45 kg/m2 (but total mass not >200 kg due to DXA measures)
• Currently consuming energy (i.e. dietary intake) over a period of 12 h or more, habitually (i.e. self-reported on 5/7 days per week)
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not a regular breakfast consumer;
• Does not have a smart phone or cannot operate the camera function on a smart phone;
• Taking more than 2 oral hypoglycaemic agents (OHAs), taking sulphonylrueas, or other glucose lowering medications (i.e. GLP-1 angonists, or insulin), or unstable use of OHA (i.e. not taking them for at least a 3 month period).
• Currently following a strict diet (i.e. vegan, coeliac/gluten free, ketogenic);
• Participate in regular fasting (defined as fasting for greater than or equal to 16 h/day or having completed twelve 24-h fasts within the past year);
• Participating in shift work (i.e. >3 h between 10 pm and 5 am for 1 day per week (>50 days per year))
• Not weight stable (>5 kg change over last 3 months);
• On prescribed medications required to be taken with food in the early morning or late evening or taking other prescribed medications for <3 months;
• Current smoker (tobacco, nicotine or marijuana) or within 3 months of quitting;
• Women who are pregnant, breastfeeding (within 24 wk);
• History of psychotic disorder, current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder; does not include depression)
• Psychopharmacological treatment that has not been stable for more than 3 months;
• Medications known to promote weight gain, weight loss or interact with glucose metabolism (i.e. corticosteroids);
• Diagnosed gastrointestinal conditions, surgery (i.e. bariatric) or impaired nutrient absorption;
• Antibiotic use in previous 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary outcomes assessing the feasibility (recruitment rate and duration, retention rate, safety, adverse events, compliance and acceptability of the intervention) will be analysed through means, ranges and 95% confidence intervals, as well as narrative descriptions. Statistical evaluation of the secondary outcomes will involve multilevel mixed effects models with baseline measures of dietary intake, body fatness, and activity patterns (i.e. sedentary time) as covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/07/2018
Actual
3/08/2018
Date of last participant enrolment
Anticipated
Actual
8/09/2019
Date of last data collection
Anticipated
30/11/2019
Actual
18/11/2019
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22659 0
3065 - Fitzroy
Recruitment postcode(s) [2] 22660 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 299450 0
Charities/Societies/Foundations
Name [1] 299450 0
European Society of Clinical Nutrition and Metabolism (ESPEN) Fellowship
Country [1] 299450 0
Luxembourg
Primary sponsor type
Individual
Name
Dr Evelyn Parr
Address
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 298780 0
Individual
Name [1] 298780 0
Professor John Hawley
Address [1] 298780 0
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000
Country [1] 298780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300356 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 300356 0
Ethics committee country [1] 300356 0
Australia
Date submitted for ethics approval [1] 300356 0
22/03/2018
Approval date [1] 300356 0
17/05/2018
Ethics approval number [1] 300356 0
2018-75H

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

Contacts
Principal investigator
Name 83382 0
Dr Evelyn Parr
Address 83382 0
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000
Country 83382 0
Australia
Phone 83382 0
+61392308278
Fax 83382 0
Email 83382 0
[email protected]
Contact person for public queries
Name 83383 0
Evelyn Parr
Address 83383 0
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000
Country 83383 0
Australia
Phone 83383 0
+61392308278
Fax 83383 0
Email 83383 0
[email protected]
Contact person for scientific queries
Name 83384 0
Evelyn Parr
Address 83384 0
Exercise and Nutrition Research Program
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000
Country 83384 0
Australia
Phone 83384 0
+61392308278
Fax 83384 0
Email 83384 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
This was not approved during ethical approval.


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
EmbaseTime-restricted eating as a nutrition strategy for individuals with type 2 diabetes: A feasibility study.2020https://dx.doi.org/10.3390/nu12113228
N.B. These documents automatically identified may not have been verified by the study sponsor.