Type2 DiabetesTRIFFIDNCT03590158
Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)
A study testing TRF in people with Type2 Diabetes and Obesity, run by University of Adelaide at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Obesity
- What is being tested?
- TRF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jul 2018to 29 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Waist circumference ≥94 cm
- Weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
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).
Read the detailed description
Following a 2 week baseline monitoring phase (food intake by smartphone APP, activity by accelerometer, glucose by continuous glucose monitor), participants will attend the metabolic clinic for testing (visit 0). Body weight, body composition (by DEXA), and blood pressure will be assessed. Blood and adipose tissue samples will be collected over 24-hour period for assessment of glucose, insulin, glucoregulatory hormones, blood lipids and adipose tissue transcriptome. Glucose and insulin responses to a standardised breakfast will be measured. All food will be provided for 3 days prior to the metabolic visit. Following visit 0, 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. 24-hour glucose profiles, activity and food intake will be measured again at week 6-8. At the end of the 8 weeks, participants will return for a follow-up metabolic visit, identical to that at visit 0, except foods are provided with the 10h time frame.
- Conditions
- Type2 Diabetes, Obesity
- Being tested
- TRF
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRFBehavioural
Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
| Study group | Role | What they receive |
|---|---|---|
| TRF | Experimental | 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. Receives: Behavioral: TRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemia
Change in postprandial glucose (iAUC) following a standard breakfast
Measured: 2.5 hours
Secondary outcomes (18)
Insulin
Change in fasting and postprandial insulin following a standard breakfast.
Measured: 2.5 hours
HbA1c
Change in HbA1c
Measured: 8 weeks
Body weight
Change in body weight
Measured: 8 weeks
Body composition
Change in body fat mass and fat free mass
Measured: 8 weeks
Waist and hip circumference
Change in waist and hip circumference
Measured: 8 weeks
24-hour glucose profile
Change in 24-hour glucose profiles assessed by continuous glucose monitoring
Measured: 8 weeks
Blood pressure
Changes in systolic blood pressure and diastolic blood pressure
Measured: 8 weeks
Blood lipids
changes in blood lipid profile (total cholesterol, HDL-, LDL- cholesterol and triglycerides)
Measured: 8 weeks
Non-esterified fatty acid (NEFA)
Change in non-essential fatty acid (NEFA)
Measured: 8 weeks
Plasma gastrointestinal (GI) hormones
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.
Measured: 8 weeks
Plasma cortisol
Changes in concentration of cortisol in hourly plasma samples assessed from 6am to 12pm.
Measured: 8 weeks
Plasma Melatonin
Changes in dim light melatonin onset (DLMO) assessed from 5pm to 3am
Measured: 8 weeks
Adipose tissue transcriptome
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.
Measured: 8 weeks
Evening glycaemia
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.
Measured: 8 weeks
Physical activity and sleep
An ancillary study will measure the changes in sleep and physical activity monitored by a wrist actigraph for 14 days.
Measured: 8 weeks
Food intake and meal timing
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.
Measured: 8 weeks
Continuous glucose monitoring
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.
Measured: 8 weeks
Objective sleep
Changes in objective sleep status measured by laboratory polysomnography (PSG).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start17 Jul 2018
- Primary completion29 Jun 2019
- Study completion29 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Australia, Salk Institute for Biological Studies
- Responsible party
- Principal investigator, A/Prof Leonie Heilbronn, University of Adelaide
- Investigators
- Leonie Heilbronn, PhD, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590158
- Sponsor's protocol ID
- R20180320
- Acronym
- TRIFFID
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2018
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03590158
- Acronym / sponsor ID
- TRIFFID / R20180320
- Conditions
- Type2 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- University of South Australia, Salk Institute for Biological Studies
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Following a 2 week baseline monitoring phase (food intake by smartphone APP, activity by accelerometer, glucose by continuous glucose monitor), participants will attend the metabolic clinic for testing (visit 0). Body weight, body composition (by DEXA), and blood pressure will be assessed. Blood and adipose tissue samples will be collected over 24-hour period for assessment of glucose, insulin, glucoregulatory hormones, blood lipids and adipose tissue transcriptome. Glucose and insulin responses to a standardised breakfast will be measured. All food will be provided for 3 days prior to the metabolic visit. Following visit 0, 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. 24-hour glucose profiles, activity and food intake will be measured again at week 6-8. At the end of the 8 weeks, participants will return for a follow-up metabolic visit, identical to that at visit 0, except foods are provided with the 10h time frame.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRF | Experimental | Behavioral: TRFParticipants 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Waist circumference ≥94 cm
- Weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRFParticipants will be instructed to consume their habitual diet within a self-selected 10 hour period every day. | Behavioural | TRF |
Primary outcome
Glycaemia
Time frame: 2.5 hours
Change in postprandial glucose (iAUC) following a standard breakfast
18 secondary outcomes
Insulin
Time frame: 2.5 hours
HbA1c
Time frame: 8 weeks
Body weight
Time frame: 8 weeks
Body composition
Time frame: 8 weeks
Waist and hip circumference
Time frame: 8 weeks
24-hour glucose profile
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Blood lipids
Time frame: 8 weeks
Non-esterified fatty acid (NEFA)
Time frame: 8 weeks
Plasma gastrointestinal (GI) hormones
Time frame: 8 weeks
Plasma cortisol
Time frame: 8 weeks
Plasma Melatonin
Time frame: 8 weeks
Adipose tissue transcriptome
Time frame: 8 weeks
Evening glycaemia
Time frame: 8 weeks
Physical activity and sleep
Time frame: 8 weeks
Food intake and meal timing
Time frame: 8 weeks
Continuous glucose monitoring
Time frame: 8 weeks
Objective sleep
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonie Heilbronn, PhD principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRF in people with Type2 Diabetes and Obesity, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemia (time frame: 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.