Back to resultsTime-restricted Eating in Survivors Trial (TEST)
Primary Purpose
Cancer, Breast
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Time-restricted eating
Sponsored by
About this trial
This is an interventional prevention trial for Cancer, Breast
Eligibility Criteria
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
Sites / Locations
- Edmonton Clinic Health Academy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Weekday time-restricted eating
Arm 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.
Outcomes
Primary Outcome Measures
Framingham 10-year cardiovascular risk score (%)
Calculated using the Canadian Cardiovascular scoring system
Secondary Outcome Measures
Visceral adipose tissue
measured via magnetic resonance fat-water separation imaging
Thigh adipose tissue fraction
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
Relative measure of amount of adipose tissue within the liver
Cardiorespiratory fitness
Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test
Resting energy expenditure
Collected via metabolic cart in supine resting position after overnight fast
Respiratory quotient
Collected via metabolic cart in supine resting position after overnight fast
Lipid profile
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Hemoglobin A1c
Collected via analysis of blood sample by Lifelabs commercial laboratory
Waist circumference
measured as the average of two measurements to the nearest 0.5 cm.
Fasting glucose
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Fasting insulin
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Resting systolic and diastolic blood pressure
measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device
Body mass
measured by physicians scale after overnight fast
Whole-body fat mass
estimated using8-point bioelectric impedance (Seca)
Whole-body fat-free mass
estimated using8-point bioelectric impedance (Seca)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05639829
Brief Title
Time-restricted Eating in Survivors Trial
Acronym
TEST
Official Title
Time-restricted Eating in Survivors Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
July 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weekday time-restricted eating
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating
Other Intervention Name(s)
intermittent fasting
Intervention Description
Restriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period
Primary Outcome Measure Information:
Title
Framingham 10-year cardiovascular risk score (%)
Description
Calculated using the Canadian Cardiovascular scoring system
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Visceral adipose tissue
Description
measured via magnetic resonance fat-water separation imaging
Time Frame
8 weeks
Title
Thigh adipose tissue fraction
Description
Relative measure of amount of inter+intra muscular adipose tissue within the thigh muscle measured via magnetic resonance fat-water separation imaging
Time Frame
8 weeks
Title
Liver adipose tissue fraction
Description
Relative measure of amount of adipose tissue within the liver
Time Frame
8 weeks
Title
Cardiorespiratory fitness
Description
Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test
Time Frame
8 weeks
Title
Resting energy expenditure
Description
Collected via metabolic cart in supine resting position after overnight fast
Time Frame
8 weeks
Title
Respiratory quotient
Description
Collected via metabolic cart in supine resting position after overnight fast
Time Frame
8 weeks
Title
Lipid profile
Description
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Time Frame
8 weeks
Title
Hemoglobin A1c
Description
Collected via analysis of blood sample by Lifelabs commercial laboratory
Time Frame
8 weeks
Title
Waist circumference
Description
measured as the average of two measurements to the nearest 0.5 cm.
Time Frame
8 weeks
Title
Fasting glucose
Description
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Time Frame
8 weeks
Title
Fasting insulin
Description
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Time Frame
8 weeks
Title
Resting systolic and diastolic blood pressure
Description
measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device
Time Frame
8 weeks
Title
Body mass
Description
measured by physicians scale after overnight fast
Time Frame
8 weeks
Title
Whole-body fat mass
Description
estimated using8-point bioelectric impedance (Seca)
Time Frame
8 weeks
Title
Whole-body fat-free mass
Description
estimated using8-point bioelectric impedance (Seca)
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Dietary intake
Description
Measured via diet records on 3 consecutive weekdays that were analyzed via Food Processor Nutrition Analysis Software
Time Frame
8 weeks
Title
Activity
Description
24-hour Measured via Sensewear Pro accelerometer worn on the arm for 3 consecutive weekdays
Time Frame
Change between measurement at baseline and 8 weeks
Title
Adherence to intervention
Description
Collected via participant responses to automated text messages asking participants to self-report the time they started and stopped eating each day. Calculated as the % of prescribed days to follow the intervention where participant reported performing a 16 hour or longer fast.
Time Frame
Ongoing for duration of intervention
Title
Participant acceptability
Description
assessed by a researcher-developed end of study questionnaire as: 1) a subjective difficulty rating for following TRE on a scale of 1-10 and 2) rating the dietitian and support calls as 'very helpful' or 'somewhat helpful' on a 5-point Likert scale (other options were 'neutral,' 'somewhat helpful,' and 'unhelpful')
Time Frame
8 weeks
Title
Intervention fidelity
Description
determined as completion rates of the intervention components (registered dietitian consult call, the three support calls, and response rate to the text messages)
Time Frame
8 weeks
Title
Intervention sustainability
Description
Rate of continuing to follow TRE one-month post-intervention completion (without further support or instructions) collected by phone follow-up
Time Frame
1 month post intervention
Title
Intervention sustainability confidence
Description
Average subjective rating of confidence, on 0-100% scale, in ability to follow TRE for one year or longer
Time Frame
8 weeks
Title
Intervention delivery cost
Description
Estimated as average time spent by personnel on intervention delivery multiplied by the hourly rate for that personnel
Time Frame
Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Title
Symptoms
Description
Collected at each of the support phone calls at weeks 1, 3, 6 of the intervention. The research coordinator asked participants if they experienced any symptoms on a pre-determined list or any additional symptoms. Symptoms were only recorded if the participant reported that they were related to the intervention or were unsure if they were related. Symptoms attributed to other life events (i.e., heat wave, stress at work) were not recorded.
Time Frame
Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Edmonton Clinic Health Academy
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Time-restricted Eating in Survivors Trial
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