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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

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
Timepoint [1] 0 0
2.5 hours
Secondary outcome [1] 0 0
Insulin
Timepoint [1] 0 0
2.5 hours
Secondary outcome [2] 0 0
HbA1c
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Body weight
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Body composition
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Waist and hip circumference
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
24-hour glucose profile
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Blood pressure
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Blood lipids
Timepoint [8] 0 0
8 weeks
Secondary outcome [9] 0 0
Non-esterified fatty acid (NEFA)
Timepoint [9] 0 0
8 weeks
Secondary outcome [10] 0 0
Plasma gastrointestinal (GI) hormones
Timepoint [10] 0 0
8 weeks
Secondary outcome [11] 0 0
Plasma cortisol
Timepoint [11] 0 0
8 weeks
Secondary outcome [12] 0 0
Plasma Melatonin
Timepoint [12] 0 0
8 weeks
Secondary outcome [13] 0 0
Adipose tissue transcriptome
Timepoint [13] 0 0
8 weeks
Secondary outcome [14] 0 0
Evening glycaemia
Timepoint [14] 0 0
8 weeks
Secondary outcome [15] 0 0
Physical activity and sleep
Timepoint [15] 0 0
8 weeks
Secondary outcome [16] 0 0
Food intake and meal timing
Timepoint [16] 0 0
8 weeks
Secondary outcome [17] 0 0
Continuous glucose monitoring
Timepoint [17] 0 0
8 weeks
Secondary outcome [18] 0 0
Objective sleep
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
NA
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
NA
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
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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