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

June 12, 2019 updated by: Douglas Seals, University of Colorado, Boulder
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • Integrative Physiology of Aging Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normal Feeding
Subjects will be instructed to eat within their normal feeding window.
Experimental: 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.
Behavioral: Time Restricted Feeding
consuming all daily calories within an 8 hour feeding window
Other Names:
  • TRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelium Dependent Dilation
Time Frame: 6 weeks
Brachial Artery Flow-Mediated Dilation (FMD)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Stiffness
Time Frame: 6 weeks
Aortic Pulse Wave Velocity (PWV)
6 weeks
Cognitive Function
Time Frame: 6 weeks
NIH Toolbox Cognitive Function Battery
6 weeks
Motor Function
Time Frame: 6 weeks
NIH Toolbox Motor Function Battery
6 weeks
Metabolic Function
Time Frame: 6 weeks
Oral glucose tolerance test (OGTT)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Boulder

Collaborators

Colorado State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-0108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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