Clinical trial NCT02970188: The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
Official title: The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Aging
Keywords: time restricted feeding
endothelial function
arterial stiffness
intermittent fasting
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: Colorado State University
First posted: 2016-11-21
Enrollment: 12
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelium Dependent Dilation
timeFrame: 6 weeks
Secondary outcomes:
measure: Arterial Stiffness
timeFrame: 6 weeks
measure: Cognitive Function
timeFrame: 6 weeks
measure: Motor Function
timeFrame: 6 weeks
measure: Metabolic Function
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Integrative Physiology of Aging Laboratory
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Christopher R Martens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.