Aging Clinical Trial
Official title:
The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
Verified date | June 2019 |
Source | University of Colorado, Boulder |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | September 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 79 Years |
Eligibility |
Inclusion Criteria: - Ability to provide informed consent - Baseline brachial flow-mediated dilation (FMD) < 6%? (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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Integrative Physiology of Aging Laboratory | Boulder | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Boulder | Colorado State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelium Dependent Dilation | Brachial Artery Flow-Mediated Dilation (FMD) | 6 weeks | |
Secondary | Arterial Stiffness | Aortic Pulse Wave Velocity (PWV) | 6 weeks | |
Secondary | Cognitive Function | NIH Toolbox Cognitive Function Battery | 6 weeks | |
Secondary | Motor Function | NIH Toolbox Motor Function Battery | 6 weeks | |
Secondary | Metabolic Function | Oral glucose tolerance test (OGTT) | 6 weeks |
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