MedPath

Time-restricted Eating in Survivors Trial

Not Applicable
Completed
Conditions
Cancer, Breast
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Framingham 10-year cardiovascular risk score (%)8 weeks

Calculated using the Canadian Cardiovascular scoring system

Secondary Outcome Measures
NameTimeMethod
Resting energy expenditure8 weeks

Collected via metabolic cart in supine resting position after overnight fast

Lipid profile8 weeks

Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

Visceral adipose tissue8 weeks

measured via magnetic resonance fat-water separation imaging

Thigh adipose tissue fraction8 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 fraction8 weeks

Relative measure of amount of adipose tissue within the liver

Cardiorespiratory fitness8 weeks

Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test

Fasting insulin8 weeks

Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

Resting systolic and diastolic blood pressure8 weeks

measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device

Respiratory quotient8 weeks

Collected via metabolic cart in supine resting position after overnight fast

Body mass8 weeks

measured by physicians scale after overnight fast

Hemoglobin A1c8 weeks

Collected via analysis of blood sample by Lifelabs commercial laboratory

Fasting glucose8 weeks

Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

Whole-body fat mass8 weeks

estimated using8-point bioelectric impedance (Seca)

Whole-body fat-free mass8 weeks

estimated using8-point bioelectric impedance (Seca)

Waist circumference8 weeks

measured as the average of two measurements to the nearest 0.5 cm.

Trial Locations

Locations (1)

Edmonton Clinic Health Academy

🇨🇦

Edmonton, Alberta, Canada

Edmonton Clinic Health Academy
🇨🇦Edmonton, Alberta, Canada

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