Clinical trial · Interventional
Time-restricted Eating in Survivors Trial
NCT05639829CI-TRIAL-00065527TESTcompletedN/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)
Breast cancer survivors aged 60+ and with overweight/obesity who had completed chemotherapy 1-6 years earlier completed 8 weeks of 12-8 pm weekday-only time-restricted eating. The intervention was delivered by a registered dietitian call, twice-daily automated text messages asking about eating start/stop times, and three support phone calls.
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 |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Time-restricted eating | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Weekday time-restricted eating
- description
- The intervention consisted of 8 weeks of ad libitum TRE with a 12-8 pm 8-hour eating window on weekdays. Participants received instructions to only consume water, black coffee, or black tea from 8 pm to 12 pm on weekdays and during the weekend, where there were no restrictions on eating timing. No other dietary or physical activity instructions were given.
- interventionNames
- Behavioral: Time-restricted eating
Primary outcomes (1)
- measure
- Framingham 10-year cardiovascular risk score (%)
- timeFrame
- 8 weeks
- description
- Calculated using the Canadian Cardiovascular scoring system
Secondary outcomes (15)
- measure
- Visceral adipose tissue
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * history of early-stage (I-III) breast cancer * completed anthracycline-based chemotherapy 1-6 years earlier * aged ≥60 years * had a body mass index (BMI) \>25 kg/m2 Exclusion Criteria: * taking lipid, glucose, or weight-lowering medications * contraindications to maximal exercise testing or research MRI * unstable thyroid disorder * self-reported history of an eating disorder * self-reported diagnosis of type 1 or 2 diabetes * weight loss of ≥15 lbs in previous 3 months * working night shifts * could not provide consent in English
References
Publications (0)
Data not yet available
No reference posted for this study.