We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
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

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 21, 2016
Last Update Posted Date June 14, 2019
Study Start Date  ICMJE April 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Endothelium Dependent Dilation [ Time Frame: 6 weeks ]
Brachial Artery Flow-Mediated Dilation (FMD)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Arterial Stiffness [ Time Frame: 6 weeks ]
    Aortic Pulse Wave Velocity (PWV)
  • Cognitive Function [ Time Frame: 6 weeks ]
    NIH Toolbox Cognitive Function Battery
  • Motor Function [ Time Frame: 6 weeks ]
    NIH Toolbox Motor Function Battery
  • Metabolic Function [ Time Frame: 6 weeks ]
    Oral glucose tolerance test (OGTT)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • Arterial Stiffness [ Time Frame: 6 weeks ]
    Aortic Pulse Wave Velocity (PWV)
  • Cognitive Function [ Time Frame: 6 weeks ]
    NIH Toolbox Cognitive Function Battery
  • Motor Function [ Time Frame: 6 weeks ]
    NIH Toolbox Motor Function Battery
  • Metabolic Function [ Time Frame: 6 weeks ]
    Oral glucose tolerance test (OGTT) and resting metabolic rate (RMR)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
Official Title  ICMJE The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aging
Intervention  ICMJE Behavioral: Time Restricted Feeding
consuming all daily calories within an 8 hour feeding window
Other Name: TRF
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Time Restricted Feeding
Publications * 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:CD013496. doi: 10.1002/14651858.CD013496.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970188
Other Study ID Numbers  ICMJE 15-0108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Douglas Seals, University of Colorado, Boulder
Original Responsible Party University of Colorado, Boulder
Current Study Sponsor  ICMJE University of Colorado, Boulder
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Colorado State University
Investigators  ICMJE
Principal Investigator: Christopher R Martens, Ph.D. University of Colorado, Boulder
PRS Account University of Colorado, Boulder
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP