Clinical trial · Interventional
Remote Time-restricted EAting DeliverY
Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention
NCT05454943CI-TRIAL-00096117READYcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metabolic Disturbance | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Support for TRE | Behavioral | — | UNRESOLVED |
| Peer Support for TRE | Behavioral | — | UNRESOLVED |
| Personalized TRE Protocol | Behavioral | — | UNRESOLVED |
| Standardized TRE Protocol | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Standardized TRE protocol + External Support
- description
- 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.
- interventionNames
- Behavioral: Standardized TRE Protocol
- Behavioral: External Support for TRE
- type
- EXPERIMENTAL
- label
- Standardized TRE protocol + Peer Support
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (1)
- DERIVEDSibley 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. PMID 42586905