Time-restricted Eating in Survivors Trial

Cancer, Breast Clinical Trial

— TEST  

Official title:

Time-restricted Eating in Survivors Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05639829
• Other study ID #: HREBA.CC-20-0077
• Status: Completed
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: July 28, 2021

Study information

• Verified date: November 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast

Intervention

Behavioral:
• Time-restricted eating
Restriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period

Locations

Country	Name	City	State
Canada	Edmonton Clinic Health Academy	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary intake	Measured via diet records on 3 consecutive weekdays that were analyzed via Food Processor Nutrition Analysis Software	8 weeks
Other	Activity	24-hour Measured via Sensewear Pro accelerometer worn on the arm for 3 consecutive weekdays	Change between measurement at baseline and 8 weeks
Other	Adherence to intervention	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.	Ongoing for duration of intervention
Other	Participant acceptability	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')	8 weeks
Other	Intervention fidelity	determined as completion rates of the intervention components (registered dietitian consult call, the three support calls, and response rate to the text messages)	8 weeks
Other	Intervention sustainability	Rate of continuing to follow TRE one-month post-intervention completion (without further support or instructions) collected by phone follow-up	1 month post intervention
Other	Intervention sustainability confidence	Average subjective rating of confidence, on 0-100% scale, in ability to follow TRE for one year or longer	8 weeks
Other	Intervention delivery cost	Estimated as average time spent by personnel on intervention delivery multiplied by the hourly rate for that personnel	Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Other	Symptoms	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.	Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Primary	Framingham 10-year cardiovascular risk score (%)	Calculated using the Canadian Cardiovascular scoring system	8 weeks
Secondary	Visceral adipose tissue	measured via magnetic resonance fat-water separation imaging	8 weeks
Secondary	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	8 weeks
Secondary	Liver adipose tissue fraction	Relative measure of amount of adipose tissue within the liver	8 weeks
Secondary	Cardiorespiratory fitness	Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test	8 weeks
Secondary	Resting energy expenditure	Collected via metabolic cart in supine resting position after overnight fast	8 weeks
Secondary	Respiratory quotient	Collected via metabolic cart in supine resting position after overnight fast	8 weeks
Secondary	Lipid profile	Collected via analysis of fasting blood sample by Lifelabs commercial laboratory	8 weeks
Secondary	Hemoglobin A1c	Collected via analysis of blood sample by Lifelabs commercial laboratory	8 weeks
Secondary	Waist circumference	measured as the average of two measurements to the nearest 0.5 cm.	8 weeks
Secondary	Fasting glucose	Collected via analysis of fasting blood sample by Lifelabs commercial laboratory	8 weeks
Secondary	Fasting insulin	Collected via analysis of fasting blood sample by Lifelabs commercial laboratory	8 weeks
Secondary	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	8 weeks
Secondary	Body mass	measured by physicians scale after overnight fast	8 weeks
Secondary	Whole-body fat mass	estimated using8-point bioelectric impedance (Seca)	8 weeks
Secondary	Whole-body fat-free mass	estimated using8-point bioelectric impedance (Seca)	8 weeks