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临床试验/NCT02970188
NCT02970188
Unknown
1 期

The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults

University of Colorado, Boulder1 个研究点 分布在 1 个国家目标入组 12 人2016年4月
适应症Aging

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Aging
发起方
University of Colorado, Boulder
入组人数
12
试验地点
1
主要终点
Endothelium Dependent Dilation
最后更新
6年前

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.

注册库
clinicaltrials.gov
开始日期
2016年4月
结束日期
2019年9月
最后更新
6年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Douglas Seals

Professor

University of Colorado, Boulder

入排标准

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.

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

  • Metabolic Function(6 weeks)
  • Cognitive Function(6 weeks)
  • Arterial Stiffness(6 weeks)
  • Motor Function(6 weeks)

研究点 (1)

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