Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Adherence to TRE for the 16-week intervention
研究概览
简要总结
This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Adherence to TRE for the 16-week intervention
时间窗: 16-week average
Assessed daily through twice daily automated text messages asking participants to respond with what time they started and stopped eating that day.
Hemoglobin A1c
时间窗: 16 Weeks
Collected via venipuncture
次要结局
- Body weight(16 Weeks)
- 10-year cardiovascular disease risk(16 Weeks)
- Metabolic syndrome (NCEP/ATP III criteria)(16 Weeks)
- Metabolic syndrome z-score(16 Weeks)
- Lipid profile(16 Weeks)
- Cost of intervention delivery(16 Weeks)
- TRE Adverse Events(16 Weeks)
- Free-living glucose control(16 Weeks)
- C-Reactive Protein(16 Weeks)
- Waist circumference(16 weeks)
- HOMA-IR(16 Weeks)
- Blood Pressure(16 Weeks)
- Alanine Aminotransferase(16 Weeks)
- TRE acceptability and appropriateness(16 Weeks)
- Sleep duration(16 Weeks)
- Sedentary time(16 Weeks)
- Physical activity(16 Weeks)
- TRE Adoption(16 Weeks)
- TRE Sustainability(1, 2, 3, and 4 months post intervention period)
- Health-related quality of life(16 Weeks)
研究者
Amy Kirkham
Amy Kirkham, Assistant Professor
University of Toronto