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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02970188
Enrollment
12
Registered
2016-11-21
Start date
2016-04-30
Completion date
2019-09-30
Last updated
2019-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

time restricted feeding, endothelial function, arterial stiffness, intermittent fasting

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.

Interventions

BEHAVIORALTime Restricted Feeding

consuming all daily calories within an 8 hour feeding window

Sponsors

Colorado State University
CollaboratorOTHER
University of Colorado, Boulder
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 79 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelium Dependent Dilation6 weeksBrachial Artery Flow-Mediated Dilation (FMD)

Secondary

MeasureTime frameDescription
Cognitive Function6 weeksNIH Toolbox Cognitive Function Battery
Arterial Stiffness6 weeksAortic Pulse Wave Velocity (PWV)
Motor Function6 weeksNIH Toolbox Motor Function Battery
Metabolic Function6 weeksOral glucose tolerance test (OGTT)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026