The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
研究概览
简要总结
Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 67 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 and ≤ 67;
- •Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL). A1c lab and/or fasting glucose criteria will need to be met within 12 months of signing consent form, can be obtained from prior lab result or study prescreening testing;
- •Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;
排除标准
- •Tobacco use (current or within last 2 years);
- •Active malignancy or history of cancer;
- •History of known liver disease (by serology: aspartate aminotransferase or alanine aminotransferase ≥ 3 times above upper limit of normal determined by lab review, imaging or biopsy: determined by patient history);
- •History of kidney disease (patient history and/or estimated glomerular filtration rate less than 45 mL/min/1.73m²);
- •History of diabetes mellitus:
- •History of cardiovascular disease (MI, CHF);
- •Current prescription medication use for diabetes;
- •Medication affecting glucose metabolism or appetite or immunosuppression;
- •Dietary restrictions: currently following vegetarian or vegan dietary pattern;
- •Currently following intermittent fasting or time restricted feeding pattern or use in the last 3 months;
- •Night shift worker (work schedule does not involve any period of work from 10 PM to 5 AM either on a regular or rotating basis);
- •History of weight loss >5% in the last 3 months;
- •History of weight loss surgery.
- •BMI≥40 kg/m² exclusion;
- •After informed consent and run in period: Insufficient documented food photography/annotated entries (does not log at least two entries a day for 10 of 14 days) during run in period will be excluded from randomization in to the intervention period.
研究组 & 干预措施
Time restricted feeding
daily eating period of 8 hours, before 8 PM for 12 weeks
干预措施: Time restricted feeding (Behavioral)
Control
daily eating period ≥ 12 hours for 12 weeks
干预措施: Control (Behavioral)
结局指标
主要结局
Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
时间窗: Visit 1 (0 weeks), Visit 2 (14 weeks)
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Change in sRAGE(Soluble Receptor for AGE) Levels
时间窗: Visit 1 (0 weeks), Visit 2 (14 weeks)
Estimated mean levels within the intervention and the control groups of the study. Effect size will estimated via 95% confidence intervals within and between groups.
Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.
时间窗: Visit 1 (0 weeks), Visit 2 (14 weeks)
Percentage of dietary visits that participant reported compliance with randomized eating period.
次要结局
- Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Change in Fasting Insulin Levels(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Difference in Glasgow Prognostic Scoring System(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Change in 24 Hour Urinary AGE Levels(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Adherence to Virtual Visit With Psychologist or Dietician(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries.(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Mean Glucose at Visit 2(Final 14 days of intervention period (Visit 2).)
- Glucose Management Indicator (GMI) at Visit 2(Visit 2 (14 weeks))
- Glucose Variability at Visit 2(Visit 2 (14 weeks))
- Change in Fasting Insulin Levels(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Percentage of Participants With Stable Chronotype Between Baseline and End of Study(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Difference in Glasgow Prognostic Scoring System(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Adherence to Virtual Visit With Psychologist or Dietician(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Change in 24 Hour Urinary AGE Levels(Visit 1 (0 weeks), Visit 2 (14 weeks))
- Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries.(Visit 1 (0 weeks), Visit 2 (14 weeks))