The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
- Conditions
- Aging
- Interventions
- Behavioral: Time Restricted Feeding
- Registration Number
- NCT02970188
- Lead Sponsor
- University of Colorado, Boulder
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Time Restricted Feeding 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.
- Primary Outcome Measures
Name Time Method Endothelium Dependent Dilation 6 weeks Brachial Artery Flow-Mediated Dilation (FMD)
- Secondary Outcome Measures
Name Time Method Cognitive Function 6 weeks NIH Toolbox Cognitive Function Battery
Metabolic Function 6 weeks Oral glucose tolerance test (OGTT)
Arterial Stiffness 6 weeks Aortic Pulse Wave Velocity (PWV)
Motor Function 6 weeks NIH Toolbox Motor Function Battery
Trial Locations
- Locations (1)
Integrative Physiology of Aging Laboratory
🇺🇸Boulder, Colorado, United States