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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

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

Clinicaltrials.gov identifier NCT02970188

Recruitment Status Active, not recruiting

First Posted November 21, 2016

Last update posted June 14, 2019

Study Description

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:Aging
  • Intervention/Treatment: Behavioral: Time Restricted Feeding
  • Phase: 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
  • Study Type: Interventional
  • 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
  • Estimated Primary Completion Date: January 2019
  • Actual Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
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
Outcome Measures
  • 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
  • Ages Eligible for Study: 55 to 79 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Inclusion Criteria:

- Ability to provide informed consent

- Baseline brachial flow-mediated dilation (FMD) 1 year.

Exclusion Criteria:

- Ages 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

United States, Colorado
Integrative Physiology of Aging Laboratory

Sponsors and Collaborators

University of Colorado, Boulder

Colorado State University


Principal Investigator: Christopher R Martens, Ph.D. University of Colorado, Boulder

More Information
  • Responsible Party: University of Colorado, Boulder
  • ClinicalTrials.gov Identifier: NCT02970188 History of Changes
  • 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
  • Plan to Share IPD: No
  • Keywords provided by University of Colorado, Boulder: intermittent fasting
    time restricted feeding
    endothelial function
    arterial stiffness