Remote Time-restricted EAting DeliverY

Metabolic Disturbance Clinical Trial

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Official title:

Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05454943
• Other study ID #: RIS42756
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: December 6, 2023

Study information

• Verified date: May 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.

Description:

TRE is an eating pattern where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE is a simple and accessible lifestyle intervention with high adherence potential that may target both biological and behavioural mechanisms of breast cancer risk.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: December 6, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Females
• No cancer history
• =50 years old
• Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score)
• Access to an Ontario Lifelabs location
• Owns a smartphone with Bluetooth capability with Apple or Android operating system

Exclusion Criteria:

• Type 1 diabetes
• Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists
• Self-reported history of an eating disorder
• BMI <18.5 kg/m
• Working night or rotating shifts
• Eating window <12 hours or consistently eating less than 3 meals/day in the past 3 months
• Major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet)

Related Conditions & MeSH terms

• Metabolic Disturbance

Intervention

Behavioral:
• Standardized TRE Protocol
A standardized 16:8 TRE protocol with an 11 am to 7 pm eating window.
• Personalized TRE Protocol
A personalized TRE protocol following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends =3h before bedtime; 3) if days off are required, aim to do so after following TRE for =5 successive days each week.
• External Support for TRE
External support (from study staff) that includes consultation with a registered dietitian and ongoing tailored feedback via support calls at weeks 1, 3, 6, and 12.
• Peer Support for TRE
Matched pairs will meet by phone/video at weeks 1, 3, 6, and 12.

Locations

Country	Name	City	State
Canada	Remote Ontario-wide	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety	Evaluated via the Hospital Anxiety and Depression Scale (HADS); This 14-item questionnaire has a minimum score of 0 and maximum of 21, where a higher score is worse.	16 weeks
Other	Depression	Evaluated via the Hospital Anxiety and Depression Scale (HADS); This 14-item questionnaire has a minimum score of 0 and maximum of 21, where a higher score is worse.	16 weeks
Primary	Adherence to TRE for the 16-week intervention	Assessed daily through twice daily automated text messages asking participants to respond with what time they started and stopped eating that day.	16-week average
Primary	Hemoglobin A1c	Collected via venipuncture	16 Weeks
Secondary	HOMA-IR	Homeostatic Model Assessment for Insulin Resistance calculated as fasting glucose in mmol/l*fasting insulin in µU/ml/22.5	16 Weeks
Secondary	Free-living glucose control	Participants will be provided with a Dexcom G6 continuous glucose monitor transmitter and sensor. This data will be evaluated as the 5-day average of: 24-hour, daytime, and nocturnal glucose concentration, time in hyper, normo and hypoglycemia, and glycemic variability	16 Weeks
Secondary	C-Reactive Protein	Measured via venipuncture and core lab lab analysis	16 Weeks
Secondary	Lipid profile	Measured via venipuncture and core lab lab analysis	16 Weeks
Secondary	Body weight	Measured via Fitbit Aria Air scale at baseline and 16-weeks but also once per week to evaluate trajectory of change	16 Weeks
Secondary	Waist circumference	Measured via provided circumference measuring tape as the average of 2 measurements	16 weeks
Secondary	Blood Pressure	Participant will be provided with a Bios 3al1-3e blood pressure measuring device. After 5 minutes of quiet seated rest, blood pressure will be measured 6 times, 60 seconds apart in a standardized seated position with the average of the 2nd through 6th measurement used.	16 Weeks
Secondary	10-year cardiovascular disease risk	Calculated via both the Framingham and Reynolds 10-year CVD risk scores using measured collected for study purposes (i.e., age, total cholesterol, HDL, systolic blood pressure, smoking status, C-reactive protein, family history of heart disease).	16 Weeks
Secondary	Metabolic syndrome (NCEP/ATP III criteria)	As defined by the NCEP/ATP III criteria using measurements taken using provided study tools	16 Weeks
Secondary	Metabolic syndrome z-score	As defined by the NCEP/ATP III criteria and age and ethnic specific calculations	16 Weeks
Secondary	Alanine Aminotransferase	Measured via venipuncture and core lab lab analysis	16 Weeks
Secondary	TRE acceptability and appropriateness	Evaluated via an 'End of Study Survey' (including a Diet Satisfaction Score Tool and acceptability questions) and semi-structured qualitative interviews	16 Weeks
Secondary	TRE Adoption	Evaluated as uptake of each delivery model, defined as adherence to the intervention touch points (i.e., external support: support calls with staff; peer support: number of peer interactions; both: response rate to adherence).	16 Weeks
Secondary	Cost of intervention delivery	Intervention costs will be evaluated and averaged per participant from the time required for intervention phone calls, scheduling, and technical support for adherence app by the study staff according to hourly rates of pay.	16 Weeks
Secondary	TRE Sustainability	Evaluated via participant self-report of continued TRE post-intervention	1, 2, 3, and 4 months post intervention period
Secondary	TRE Adverse Events	Measured via experience of selected relevant Common Terminology Criteria for Adverse Events (CTCAE v5) with additional questions about duration and change in the revised 18-item version of the Three-Factor Eating Questionnaire (aka Eating Inventory)	16 Weeks
Secondary	Health-related quality of life	Measured by the RAND-36 Physical Component Summary. Physical component summary of the RAND-36 questionnaire (minimum = 0, maximum = 50, a higher score is a better outcome)	16 Weeks
Secondary	Sleep duration	Measured via FitBit Inspire 2 as 7-day average	16 Weeks
Secondary	Sedentary time	Measured via FitBit Inspire 2 as 7-day average	16 Weeks
Secondary	Physical activity	Measured via FitBit Inspire 2 as 7-day average	16 Weeks