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/show/NCT03590158




Registration number
NCT03590158
Ethics application status
Date submitted
12/07/2018
Date registered
12/07/2018
Date last updated
28/11/2018

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
Behaviour - TRF

Experimental: TRF - Participants will be instructed to eat 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 at least 3 hours prior to their usual bedtime.


Behaviour: TRF
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycaemia - Change in fasting and postprandial glucose following a standard breakfast
Timepoint [1] 0 0
2.5 hours
Secondary outcome [1] 0 0
Insulin - Change in fasting and postprandial insulin following a standard breakfast.
Timepoint [1] 0 0
2.5 hours
Secondary outcome [2] 0 0
HbA1c - Change in HbA1c
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Body weight - Change in body weight
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Body composition - Change in body fat mass and fat free mass
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Waist and hip circumference - Change in waist and hip circumference and waist: hip ratio
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
24-hour glucose profile - Change in 24-hour glucose profiles assessed by continuous glucose monitoring
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Blood pressure - Changes in systolic blood pressure and diastolic blood pressure
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Blood lipids - 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) - Change in non-essential fatty acid (NEFA)
Timepoint [9] 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
Gender
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
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of South Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Salk Institute for Biological Studies
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will explore the effects of eight weeks of time-restricted feeding (TRF) on body
weight and composition, glycaemic control, 24-hour glucose profiles and cardiovascular risk
in men at high risk of type 2 diabetes.The investigators hypothesise that 8 weeks of TRF will
reduce body weight, improve body composition,improve glycaemic control and blood lipid
profiles.
Trial website
https://clinicaltrials.gov/show/NCT03590158
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Hutchison, PhD
Address 0 0
Country 0 0
Phone 0 0
8128 4862
Fax 0 0
Email 0 0
amy.hutchison@adelaide.edu.au
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable