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临床试验/NCT05639829
NCT05639829已完成不适用

Time-restricted Eating in Survivors Trial

University of Alberta1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Framingham 10-year cardiovascular risk score (%)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Framingham 10-year cardiovascular risk score (%)

时间窗: 8 weeks

Calculated using the Canadian Cardiovascular scoring system

次要结局

  • Resting energy expenditure(8 weeks)
  • Lipid profile(8 weeks)
  • Visceral adipose tissue(8 weeks)
  • Thigh adipose tissue fraction(8 weeks)
  • Liver adipose tissue fraction(8 weeks)
  • Cardiorespiratory fitness(8 weeks)
  • Fasting insulin(8 weeks)
  • Resting systolic and diastolic blood pressure(8 weeks)
  • Body mass(8 weeks)
  • Respiratory quotient(8 weeks)
  • Hemoglobin A1c(8 weeks)
  • Waist circumference(8 weeks)
  • Fasting glucose(8 weeks)
  • Whole-body fat mass(8 weeks)
  • Whole-body fat-free mass(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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