Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03590158




Registration number
NCT03590158
Ethics application status
Date submitted
12/07/2018
Date registered
18/07/2018
Date last updated
30/07/2019

Titles & IDs
Public title
Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)
Scientific title
The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
Secondary ID [1] 0 0
R20180320
Universal Trial Number (UTN)
Trial acronym
TRIFFID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type2 Diabetes 0 0
Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - TRF

Experimental: TRF - Participants will follow their regular diet for two weeks before 3-day lead-in food prior to the metabolic testing at visit 0. Participants will then be instructed to eat their habitual diet only within a 10-hour time frame each day for 8 weeks. Participants may self-select the precise window that best suits their lifestyles, however any food and drink must be consumed by 7:30pm.


BEHAVIORAL: TRF
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycaemia
Assessment method [1] 0 0
Change in postprandial glucose (iAUC) following a standard breakfast
Timepoint [1] 0 0
2.5 hours
Secondary outcome [1] 0 0
Insulin
Assessment method [1] 0 0
Change in fasting and postprandial insulin following a standard breakfast.
Timepoint [1] 0 0
2.5 hours
Secondary outcome [2] 0 0
HbA1c
Assessment method [2] 0 0
Change in HbA1c
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Body weight
Assessment method [3] 0 0
Change in body weight
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Body composition
Assessment method [4] 0 0
Change in body fat mass and fat free mass
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Waist and hip circumference
Assessment method [5] 0 0
Change in waist and hip circumference
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
24-hour glucose profile
Assessment method [6] 0 0
Change in 24-hour glucose profiles assessed by continuous glucose monitoring
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Blood pressure
Assessment method [7] 0 0
Changes in systolic blood pressure and diastolic blood pressure
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Blood lipids
Assessment method [8] 0 0
changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)
Timepoint [8] 0 0
8 weeks
Secondary outcome [9] 0 0
Non-esterified fatty acid (NEFA)
Assessment method [9] 0 0
Change in non-essential fatty acid (NEFA)
Timepoint [9] 0 0
8 weeks
Secondary outcome [10] 0 0
Plasma gastrointestinal (GI) hormones
Assessment method [10] 0 0
Changes in concentration of fasting and postprandial GI hormones in plasma (ghrelin, glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide, peptide YY) following a standard breakfast.
Timepoint [10] 0 0
8 weeks
Secondary outcome [11] 0 0
Plasma cortisol
Assessment method [11] 0 0
Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.
Timepoint [11] 0 0
8 weeks
Secondary outcome [12] 0 0
Plasma Melatonin
Assessment method [12] 0 0
Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am
Timepoint [12] 0 0
8 weeks
Secondary outcome [13] 0 0
Adipose tissue transcriptome
Assessment method [13] 0 0
A subset will be measured for the change in the adipose tissue transcriptome in 6-hourly samples by RNA-sequencing. The data analysis including but not limited to the changes in numbers of genes oscillated in a diurnal manner, and pathway analysis.
Timepoint [13] 0 0
8 weeks
Secondary outcome [14] 0 0
Evening glycaemia
Assessment method [14] 0 0
An ancillary study will be performed to measure the changes in the concentration of plasma glucose, insulin and GI hormones (ghrelin, glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide, peptide YY) following a standard evening meal.
Timepoint [14] 0 0
8 weeks
Secondary outcome [15] 0 0
Physical activity and sleep
Assessment method [15] 0 0
An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.
Timepoint [15] 0 0
8 weeks
Secondary outcome [16] 0 0
Food intake and meal timing
Assessment method [16] 0 0
An ancillary study will measure the changes in food intake and meal timing as recorded via a photography based smartphone App over 2 weeks. The analysis of the App data including but not limited to eating duration at baseline, changes in eating duration after intervention, calorie distribution throughout the day, meal frequency, meal intervals, and macronutrients intake.
Timepoint [16] 0 0
8 weeks
Secondary outcome [17] 0 0
Continuous glucose monitoring
Assessment method [17] 0 0
An ancillary study will measure the changes in glucose level by CGM for 14 days. Daily glucose patterns including free habitual diet, 3-day lead-in food will be measured separately. The analysis of the CGM data including but not limited to assess the mean amplitude of glycaemic excursions (MAGE), continuous overall net glycaemic action (CONGA), mean glucose concentrations.
Timepoint [17] 0 0
8 weeks
Secondary outcome [18] 0 0
Objective sleep
Assessment method [18] 0 0
Changes in objective sleep status measured by laboratory polysomnography (PSG).
Timepoint [18] 0 0
8 weeks

Eligibility
Key inclusion criteria
* Waist circumference =94 cm
* Weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry)
Minimum age
40 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Personal history and/or diagnosis of: diabetes, cancer, major psychiatric disorders, liver disease, gastro-intestinal surgery or disease (including malabsorption), eating disorders, anaemia, insomnia, cardiovascular disease deemed unstable by the study physician.
* use of prescribed or non-prescribed medications which may affect energy metabolism, gastrointestinal function, body weight or appetite, sleep (e.g: domperidone and cisapride, anticholinergic drugs (e.g.: atropine), metoclopramide, orlistat, thyroid medications, diuretics, glucocorticoids, sex steroids, metformin, dipeptidyl peptidase-IV inhibitors, melatonin)
* recent weight change in past 3 months (> 5% current body weight)
* individuals who regularly perform high intensity exercise (>2 week)
* current intake of > 140g alcohol/week
* current smokers of cigarettes/cigars/marijuana/e-cigarettes/vaporisers
* current intake of any illicit substance
* unable to comprehend study protocol
* currently performing shift work
* has undertaken, or is planning to undertake, trans meridian travel during the study period, or the preceding 60 days
* do not own a smartphone
* eats for less than a 12-hour period per day

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2019
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of South Australia
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Salk Institute for Biological Studies
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03590158