NCT02970188

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

2.8 years

First QC Date

November 18, 2016

Last Update Submit

June 12, 2019

Conditions

Aging

Keywords

time restricted feedingendothelial functionarterial stiffnessintermittent fasting

Outcome Measures

Primary Outcomes (1)

  • Endothelium Dependent Dilation

    Brachial Artery Flow-Mediated Dilation (FMD)

    6 weeks

Secondary Outcomes (4)

  • Arterial Stiffness

    6 weeks

  • Cognitive Function

    6 weeks

  • Motor Function

    6 weeks

  • Metabolic Function

    6 weeks

Study Arms (2)

Normal Feeding

NO INTERVENTION

Subjects will be instructed to eat within their normal feeding window.

Time Restricted Feeding

EXPERIMENTAL

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

Interventions

Time Restricted FeedingBEHAVIORAL

consuming all daily calories within an 8 hour feeding window

Also known as: TRF
Time Restricted Feeding

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide informed consent
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Physiology of Aging Laboratory

Boulder, Colorado, 80309, United States

Location

Related Publications (1)

  • 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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Officials

  • Christopher R Martens, Ph.D.

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 21, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

September 1, 2019

Last Updated

June 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)