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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02970188
• Other study ID #: 15-0108
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2016
• Est. completion date: September 2019

Study information

• Verified date: June 2019
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Time Restricted Feeding
consuming all daily calories within an 8 hour feeding window

Locations

Country	Name	City	State
United States	Integrative Physiology of Aging Laboratory	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

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