The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Endothelium Dependent Dilation
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of time-restricted feeding (eating within an 8-hour window) for improving physiological function (vascular, motor, cognitive and metabolic function) in healthy middle-aged and older adults.
详细描述
Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent
- •Baseline brachial flow-mediated dilation (FMD) < 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
- •Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
- •Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.
排除标准
- •Ages <55 years or ≥80 years
- •Occupation that requires night-shift work or abnormal hours that would disrupt eating schedule
- •Dietary habit of regularly skipping meals, already eating within a ~10 hour window, or any other form of restrictive eating.
- •Unable to adhere to an 8 hour eating window for the length of the study period
- •Participation in regular vigorous aerobic/endurance exercise (>3 vigorous bouts/week)
- •Not weight stable in the prior 3 months (>2 kg weight change).
- •Body mass index (BMI) >40 kg/m^2 (rationale: vascular function measurements can be inaccurate in severely obese subjects)
- •Current smoking
- •Diagnosis of a chronic clinical disease (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging]), except hypertension and hyperlipidemia.
- •Having unstable angina, acute myocardial infarction, coronary angioplasty, or aorto- coronary bypass surgery as defined by the occurrence of an event, symptom, surgery, or change in medication and/or dosage within 3 months prior to enrollment.
- •Having thyroid disease that is not controlled by medications or <3 month's use of a particular medication and/or dosage (rationale: uncontrolled thyroid diseases are associated with alterations in vascular function).
- •Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
研究组 & 干预措施
Normal Feeding
Subjects will be instructed to eat within their normal feeding window.
Time Restricted Feeding
Subjects will be instructed to eat with an 8 hour feeding window, starting between 10:30-11:30 AM and stopping between 5:30-6:30 PM.
干预措施: Time Restricted Feeding (Behavioral)
结局指标
主要结局
Endothelium Dependent Dilation
时间窗: 6 weeks
Brachial Artery Flow-Mediated Dilation (FMD)
次要结局
- Motor Function(6 weeks)
- Cognitive Function(6 weeks)
- Metabolic Function(6 weeks)
- Arterial Stiffness(6 weeks)
研究者
Douglas Seals
Professor
University of Colorado, Boulder