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

Sponsor
University of Colorado, Boulder (Other)
Overall Status
Unknown status
CT.gov ID
NCT02970188
Collaborator
Colorado State University (Other)
12
Enrollment
1
Location
2
Arms
41
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2016
Actual Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endothelium Dependent Dilation [6 weeks]

      Brachial Artery Flow-Mediated Dilation (FMD)

    Secondary Outcome Measures

    1. Arterial Stiffness [6 weeks]

      Aortic Pulse Wave Velocity (PWV)

    2. Cognitive Function [6 weeks]

      NIH Toolbox Cognitive Function Battery

    3. Motor Function [6 weeks]

      NIH Toolbox Motor Function Battery

    4. Metabolic Function [6 weeks]

      Oral glucose tolerance test (OGTT)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Integrative Physiology of Aging Laboratory Boulder Colorado United States 80309

    Sponsors and Collaborators

    • University of Colorado, Boulder
    • Colorado State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Seals, Professor, University of Colorado, Boulder
    ClinicalTrials.gov Identifier:
    NCT02970188
    Other Study ID Numbers:
    • 15-0108
    First Posted:
    Nov 21, 2016
    Last Update Posted:
    Jun 14, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Douglas Seals, Professor, University of Colorado, Boulder
    time restricted feeding
    endothelial function
    arterial stiffness
    intermittent fasting

    Study Results

    No Results Posted as of Jun 14, 2019