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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
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
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
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
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, glucoregulatory hormones, 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. The potential mechanism will be explored in terms of the changes in gene expression patterns and multi-omics level (e.g., adipose tissue transcriptome, blood proteome).
Trial website
https://clinicaltrials.gov/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03590158