Clinical trial NCT05454943: Remote Time-restricted EAting DeliverY
Official title: Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Disturbance
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 178
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adherence to TRE for the 16-week intervention
timeFrame: 16-week average
measure: Hemoglobin A1c
timeFrame: 16 Weeks
Secondary outcomes:
measure: HOMA-IR
timeFrame: 16 Weeks
measure: Free-living glucose control
timeFrame: 16 Weeks
measure: C-Reactive Protein
timeFrame: 16 Weeks
measure: Lipid profile
timeFrame: 16 Weeks
measure: Body weight
timeFrame: 16 Weeks
measure: Waist circumference
timeFrame: 16 weeks
measure: Blood Pressure
timeFrame: 16 Weeks
measure: 10-year cardiovascular disease risk
timeFrame: 16 Weeks
measure: Metabolic syndrome (NCEP/ATP III criteria)
timeFrame: 16 Weeks
measure: Metabolic syndrome z-score
timeFrame: 16 Weeks
measure: Alanine Aminotransferase
timeFrame: 16 Weeks
measure: TRE acceptability and appropriateness
timeFrame: 16 Weeks
measure: TRE Adoption
timeFrame: 16 Weeks
measure: Cost of intervention delivery
timeFrame: 16 Weeks
measure: TRE Sustainability
timeFrame: 1, 2, 3, and 4 months post intervention period
measure: TRE Adverse Events
timeFrame: 16 Weeks
measure: Health-related quality of life
timeFrame: 16 Weeks
measure: Sleep duration
timeFrame: 16 Weeks
measure: Sedentary time
timeFrame: 16 Weeks
measure: Physical activity
timeFrame: 16 Weeks
Other outcomes:
measure: Anxiety
timeFrame: 16 weeks
measure: Depression
timeFrame: 16 weeks
Locations:
city: Toronto
country: Canada
facility: Remote Ontario-wide
state: Ontario
Study officials:
affiliation: University of Toronto
name: Amy A Kirkham, PhD
role: PRINCIPAL_INVESTIGATOR
References: