Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02970188
Recruitment Status : Unknown
Verified June 2019 by Douglas Seals, University of Colorado, Boulder.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2016
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Colorado State University
Information provided by (Responsible Party):
Douglas Seals, University of Colorado, Boulder

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Time Restricted Feeding Phase 1 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
Study Start Date : April 2016
Actual Primary Completion Date : January 2019
Estimated Study Completion Date : September 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: TRF


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Endothelium Dependent Dilation [ Time Frame: 6 weeks ]
    Brachial Artery Flow-Mediated Dilation (FMD)


Secondary Outcome Measures :
  1. Arterial Stiffness [ Time Frame: 6 weeks ]
    Aortic Pulse Wave Velocity (PWV)

  2. Cognitive Function [ Time Frame: 6 weeks ]
    NIH Toolbox Cognitive Function Battery

  3. Motor Function [ Time Frame: 6 weeks ]
    NIH Toolbox Motor Function Battery

  4. Metabolic Function [ Time Frame: 6 weeks ]
    Oral glucose tolerance test (OGTT)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970188


Locations
Layout table for location information
United States, Colorado
Integrative Physiology of Aging Laboratory
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Colorado State University
Investigators
Layout table for investigator information
Principal Investigator: Christopher R Martens, Ph.D. University of Colorado, Boulder
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Douglas Seals, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02970188    
Other Study ID Numbers: 15-0108
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Douglas Seals, University of Colorado, Boulder:
time restricted feeding
endothelial function
arterial stiffness
intermittent fasting