Metabolic DisturbanceREADYNCT05454943
Remote Time-restricted EAting DeliverY
A study testing Standardized TRE Protocol, Personalized TRE Protocol and External Support for TRE in people with Metabolic Disturbance, run by University of Toronto at 1 site in Canada.
Trial summary
This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance
- What is being tested?
- Standardized TRE Protocol, Personalized TRE Protocol and External Support for TRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2022to 30 Jan 2024
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females
- No cancer history
- ≥50 years old
- Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score)
- Access to an Ontario Lifelabs location
- Owns a smartphone with Bluetooth capability with Apple or Android operating system
Who cannot join
- Type 1 diabetes
- Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists
- Self-reported history of an eating disorder
- BMI <18.5 kg/m
- Working night or rotating shifts
- Eating window <12 hours or consistently eating less than 3 meals/day in the past 3 months
- Major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention
This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.
Read the detailed description
TRE is an eating pattern where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE is a simple and accessible lifestyle intervention with high adherence potential that may target both biological and behavioural mechanisms of breast cancer risk.
- Conditions
- Metabolic Disturbance
- Being tested
- Standardized TRE Protocol, Personalized TRE Protocol, External Support for TRE, Peer Support for TRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized TRE ProtocolBehavioural
A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
Personalized TRE ProtocolBehavioural
A personalized TRE protocol following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week.
External Support for TREBehavioural
External support (from study staff) that includes consultation with a registered dietitian and ongoing tailored feedback via support calls at weeks 1, 3, 6, and 12.
Peer Support for TREBehavioural
Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.
| Study group | Role | What they receive |
|---|---|---|
| Standardized TRE protocol + External Support | Experimental | Participants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12. Receives: Behavioral: Standardized TRE Protocol; Behavioral: External Support for TRE |
| Standardized TRE protocol + Peer Support | Experimental | Participants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged. Receives: Behavioral: Standardized TRE Protocol; Behavioral: Peer Support for TRE |
| Personalized TRE protocol + External Support | Experimental | Participants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12. Receives: Behavioral: Personalized TRE Protocol; Behavioral: External Support for TRE |
| Personalized TRE protocol + Peer Support | Experimental | Participants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged. Receives: Behavioral: Personalized TRE Protocol; Behavioral: Peer Support for TRE |
| Control Group | No intervention | Participants will be asked to maintain their usual diet and physical activity patterns for 16 weeks. They will receive the same number and timing of calls from study staff as the other groups (at randomization, 1, 3, 6, 12 weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to TRE for the 16-week intervention
Assessed daily through twice daily automated text messages asking participants to respond with what time they started and stopped eating that day.
Measured: 16-week average
Hemoglobin A1c
Collected via venipuncture
Measured: 16 Weeks
Secondary outcomes (20)
HOMA-IR
Homeostatic Model Assessment for Insulin Resistance calculated as fasting glucose in mmol/l*fasting insulin in μU/ml/22.5
Measured: 16 Weeks
Free-living glucose control
Participants will be provided with a Dexcom G6 continuous glucose monitor transmitter and sensor. This data will be evaluated as the 5-day average of: 24-hour, daytime, and nocturnal glucose concentration, time in hyper, normo and hypoglycemia, and glycemic variability
Measured: 16 Weeks
C-Reactive Protein
Measured via venipuncture and core lab lab analysis
Measured: 16 Weeks
Lipid profile
Measured via venipuncture and core lab lab analysis
Measured: 16 Weeks
Body weight
Measured via Fitbit Aria Air scale at baseline and 16-weeks but also once per week to evaluate trajectory of change
Measured: 16 Weeks
Waist circumference
Measured via provided circumference measuring tape as the average of 2 measurements
Measured: 16 weeks
Blood Pressure
Participant will be provided with a Bios 3al1-3e blood pressure measuring device. After 5 minutes of quiet seated rest, blood pressure will be measured 6 times, 60 seconds apart in a standardized seated position with the average of the 2nd through 6th measurement used.
Measured: 16 Weeks
10-year cardiovascular disease risk
Calculated via both the Framingham and Reynolds 10-year CVD risk scores using measured collected for study purposes (i.e., age, total cholesterol, HDL, systolic blood pressure, smoking status, C-reactive protein, family history of heart disease).
Measured: 16 Weeks
Metabolic syndrome (NCEP/ATP III criteria)
As defined by the NCEP/ATP III criteria using measurements taken using provided study tools
Measured: 16 Weeks
Metabolic syndrome z-score
As defined by the NCEP/ATP III criteria and age and ethnic specific calculations
Measured: 16 Weeks
Alanine Aminotransferase
Measured via venipuncture and core lab lab analysis
Measured: 16 Weeks
TRE acceptability and appropriateness
Evaluated via an 'End of Study Survey' (including a Diet Satisfaction Score Tool and acceptability questions) and semi-structured qualitative interviews
Measured: 16 Weeks
TRE Adoption
Evaluated as uptake of each delivery model, defined as adherence to the intervention touch points (i.e., external support: support calls with staff; peer support: number of peer interactions; both: response rate to adherence).
Measured: 16 Weeks
Cost of intervention delivery
Intervention costs will be evaluated and averaged per participant from the time required for intervention phone calls, scheduling, and technical support for adherence app by the study staff according to hourly rates of pay.
Measured: 16 Weeks
TRE Sustainability
Evaluated via participant self-report of continued TRE post-intervention
Measured: 1, 2, 3, and 4 months post intervention period
TRE Adverse Events
Measured via experience of selected relevant Common Terminology Criteria for Adverse Events (CTCAE v5) with additional questions about duration and change in the revised 18-item version of the Three-Factor Eating Questionnaire (aka Eating Inventory)
Measured: 16 Weeks
Health-related quality of life
Measured by the RAND-36 Physical Component Summary. Physical component summary of the RAND-36 questionnaire (minimum = 0, maximum = 50, a higher score is a better outcome)
Measured: 16 Weeks
Sleep duration
Measured via FitBit Inspire 2 as 7-day average
Measured: 16 Weeks
Sedentary time
Measured via FitBit Inspire 2 as 7-day average
Measured: 16 Weeks
Physical activity
Measured via FitBit Inspire 2 as 7-day average
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start7 Jul 2022
- Primary completion20 Sep 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DisturbanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Kirkham, University of Toronto
- Investigators
- Amy A Kirkham, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454943
- Sponsor's protocol ID
- RIS42756
- Acronym
- READY
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sibley D, Rishis E, Neil-Sztramko S, de Barros Gonze B, Govette A, Dojutrek A, Small S, Lee O, Christensen R, Sabiston C, Gillen J, Kirkham AA. Sleep parameters associated with cardiometabolic health in older women: a cross-sectional study. Nutr Metab Cardiovasc Dis. 2026 Jul 25:104883. doi: 10.1016/j.numecd.2026.104883. Online ahead of print.
PubMed 42586905
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention
- ClinicalTrials.gov ID
- NCT05454943
- Acronym / sponsor ID
- READY / RIS42756
- Conditions
- Metabolic Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 12 Jul 2022 (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 evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.
Detailed description
TRE is an eating pattern where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE is a simple and accessible lifestyle intervention with high adherence potential that may target both biological and behavioural mechanisms of breast cancer risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standardized TRE protocol + External Support | Experimental | Behavioral: Standardized TRE Protocol, Behavioral: External Support for TREParticipants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12. |
| Standardized TRE protocol + Peer Support | Experimental | Behavioral: Standardized TRE Protocol, Behavioral: Peer Support for TREParticipants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged. |
| Personalized TRE protocol + External Support | Experimental | Behavioral: Personalized TRE Protocol, Behavioral: External Support for TREParticipants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12. |
| Personalized TRE protocol + Peer Support | Experimental | Behavioral: Personalized TRE Protocol, Behavioral: Peer Support for TREParticipants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged. |
| Control Group | No intervention | –Participants will be asked to maintain their usual diet and physical activity patterns for 16 weeks. They will receive the same number and timing of calls from study staff as the other groups (at randomization, 1, 3, 6, 12 weeks). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females
- No cancer history
- ≥50 years old
- Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score)
- Access to an Ontario Lifelabs location
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists
- Self-reported history of an eating disorder
- BMI <18.5 kg/m
- Working night or rotating shifts
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 |
|---|---|---|
| Standardized TRE ProtocolA standardized 16:8 TRE protocol with an 11 am to 7 pm eating window. | Behavioural | Standardized TRE protocol + External Support, Standardized TRE protocol + Peer Support |
| Personalized TRE ProtocolA personalized TRE protocol following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. | Behavioural | Personalized TRE protocol + External Support, Personalized TRE protocol + Peer Support |
| External Support for TREExternal support (from study staff) that includes consultation with a registered dietitian and ongoing tailored feedback via support calls at weeks 1, 3, 6, and 12. | Behavioural | Personalized TRE protocol + External Support, Standardized TRE protocol + External Support |
| Peer Support for TREMatched pairs will meet by phone/video at weeks 1, 3, 6, and 12. | Behavioural | Personalized TRE protocol + Peer Support, Standardized TRE protocol + Peer Support |
Primary outcome
Adherence to TRE for the 16-week intervention
Time frame: 16-week average
Assessed daily through twice daily automated text messages asking participants to respond with what time they started and stopped eating that day.
Hemoglobin A1c
Time frame: 16 Weeks
Collected via venipuncture
20 secondary outcomes
HOMA-IR
Time frame: 16 Weeks
Free-living glucose control
Time frame: 16 Weeks
C-Reactive Protein
Time frame: 16 Weeks
Lipid profile
Time frame: 16 Weeks
Body weight
Time frame: 16 Weeks
Waist circumference
Time frame: 16 weeks
Blood Pressure
Time frame: 16 Weeks
10-year cardiovascular disease risk
Time frame: 16 Weeks
Metabolic syndrome (NCEP/ATP III criteria)
Time frame: 16 Weeks
Metabolic syndrome z-score
Time frame: 16 Weeks
Alanine Aminotransferase
Time frame: 16 Weeks
TRE acceptability and appropriateness
Time frame: 16 Weeks
TRE Adoption
Time frame: 16 Weeks
Cost of intervention delivery
Time frame: 16 Weeks
TRE Sustainability
Time frame: 1, 2, 3, and 4 months post intervention period
TRE Adverse Events
Time frame: 16 Weeks
Health-related quality of life
Time frame: 16 Weeks
Sleep duration
Time frame: 16 Weeks
Sedentary time
Time frame: 16 Weeks
Physical activity
Time frame: 16 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 1 Oct 2025.
- Derived from this study: PubMed 42586905Sibley D, Rishis E, Neil-Sztramko S, de Barros Gonze B, Govette A, Dojutrek A, Small S, Lee O, Christensen R, Sabiston C, Gillen J, Kirkham AA. Sleep parameters associated with cardiometabolic health in older women: a cross-sectional study. Nutr Metab Cardiovasc Dis. 2026 Jul 25:104883. doi: 10.1016/j.numecd.2026.104883. Online ahead of print.
- 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.
Amy A Kirkham, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized TRE Protocol, Personalized TRE Protocol and External Support for TRE in people with Metabolic Disturbance, run by University of Toronto at 1 site in Canada.
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 6 inclusion and 7 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 1 Oct 2025. 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 Canada. 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?
Adherence to TRE for the 16-week intervention (time frame: 16-week average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05454943, which also lists 1 linked publication.
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 1 Oct 2025.