Time-restricted Eating in Survivors Trial
- Conditions
- Cancer, Breast
- Interventions
- Behavioral: Time-restricted eating
- Registration Number
- NCT05639829
- Lead Sponsor
- University of Alberta
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Weekday time-restricted eating Time-restricted eating 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.
- Primary Outcome Measures
Name Time Method Framingham 10-year cardiovascular risk score (%) 8 weeks Calculated using the Canadian Cardiovascular scoring system
- Secondary Outcome Measures
Name Time Method Waist circumference 8 weeks measured as the average of two measurements to the nearest 0.5 cm.
Resting energy expenditure 8 weeks Collected via metabolic cart in supine resting position after overnight fast
Lipid profile 8 weeks Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Visceral adipose tissue 8 weeks measured via magnetic resonance fat-water separation imaging
Thigh adipose tissue fraction 8 weeks Relative measure of amount of inter+intra muscular adipose tissue within the thigh muscle measured via magnetic resonance fat-water separation imaging
Liver adipose tissue fraction 8 weeks Relative measure of amount of adipose tissue within the liver
Cardiorespiratory fitness 8 weeks Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test
Fasting insulin 8 weeks Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Resting systolic and diastolic blood pressure 8 weeks measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device
Respiratory quotient 8 weeks Collected via metabolic cart in supine resting position after overnight fast
Body mass 8 weeks measured by physicians scale after overnight fast
Hemoglobin A1c 8 weeks Collected via analysis of blood sample by Lifelabs commercial laboratory
Fasting glucose 8 weeks Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Whole-body fat mass 8 weeks estimated using8-point bioelectric impedance (Seca)
Whole-body fat-free mass 8 weeks estimated using8-point bioelectric impedance (Seca)
Trial Locations
- Locations (1)
Edmonton Clinic Health Academy
🇨🇦Edmonton, Alberta, Canada