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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal Feeding

Subjects will be instructed to eat within their normal feeding window.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Time Restricted Feeding

Intervention Type BEHAVIORAL

consuming all daily calories within an 8 hour feeding window

Interventions

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Time Restricted Feeding

consuming all daily calories within an 8 hour feeding window

Intervention Type BEHAVIORAL

Other Intervention Names

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TRF

Eligibility Criteria

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Inclusion Criteria

* 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.

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes