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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)
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Scientific title
The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
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Secondary ID [1]
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R20180320
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Universal Trial Number (UTN)
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Trial acronym
TRIFFID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type2 Diabetes
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Obesity
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Glycaemia
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Assessment method [1]
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Change in postprandial glucose (iAUC) following a standard breakfast
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Timepoint [1]
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2.5 hours
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Secondary outcome [1]
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Insulin
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Assessment method [1]
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Change in fasting and postprandial insulin following a standard breakfast.
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Timepoint [1]
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2.5 hours
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Secondary outcome [2]
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HbA1c
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Assessment method [2]
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Change in HbA1c
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Timepoint [2]
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8 weeks
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Secondary outcome [3]
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Body weight
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Assessment method [3]
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Change in body weight
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Timepoint [3]
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8 weeks
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Secondary outcome [4]
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Body composition
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Assessment method [4]
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Change in body fat mass and fat free mass
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Timepoint [4]
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8 weeks
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Secondary outcome [5]
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Waist and hip circumference
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Assessment method [5]
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Change in waist and hip circumference
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Timepoint [5]
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8 weeks
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Secondary outcome [6]
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24-hour glucose profile
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Assessment method [6]
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Change in 24-hour glucose profiles assessed by continuous glucose monitoring
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Timepoint [6]
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8 weeks
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Secondary outcome [7]
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Blood pressure
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Assessment method [7]
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Changes in systolic blood pressure and diastolic blood pressure
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Timepoint [7]
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8 weeks
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Secondary outcome [8]
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Blood lipids
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Assessment method [8]
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changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)
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Timepoint [8]
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8 weeks
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Secondary outcome [9]
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Non-esterified fatty acid (NEFA)
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Assessment method [9]
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Change in non-essential fatty acid (NEFA)
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Timepoint [9]
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8 weeks
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Secondary outcome [10]
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Plasma gastrointestinal (GI) hormones
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Assessment method [10]
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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.
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Timepoint [10]
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8 weeks
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Secondary outcome [11]
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Plasma cortisol
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Assessment method [11]
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Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.
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Timepoint [11]
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8 weeks
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Secondary outcome [12]
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Plasma Melatonin
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Assessment method [12]
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Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am
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Timepoint [12]
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8 weeks
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Secondary outcome [13]
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Adipose tissue transcriptome
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Assessment method [13]
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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.
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Timepoint [13]
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8 weeks
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Secondary outcome [14]
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Evening glycaemia
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Assessment method [14]
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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.
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Timepoint [14]
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8 weeks
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Secondary outcome [15]
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Physical activity and sleep
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Assessment method [15]
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An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.
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Timepoint [15]
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8 weeks
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Secondary outcome [16]
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Food intake and meal timing
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Assessment method [16]
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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.
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Timepoint [16]
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8 weeks
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Secondary outcome [17]
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Continuous glucose monitoring
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Assessment method [17]
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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.
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Timepoint [17]
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8 weeks
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Secondary outcome [18]
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Objective sleep
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Assessment method [18]
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Changes in objective sleep status measured by laboratory polysomnography (PSG).
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Timepoint [18]
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8 weeks
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Eligibility
Key inclusion criteria
* Waist circumference =94 cm
* Weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry)
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Minimum age
40
Years
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Maximum age
70
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/06/2019
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Adelaide
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of South Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Salk Institute for Biological Studies
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT03590158
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Leonie Heilbronn, PhD
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Address
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University of Adelaide
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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