AgingPhase 1/2NCT02970188
The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
A Phase 1/2 study testing Time Restricted Feeding in people with Aging, run by University of Colorado, Boulder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Time Restricted Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Physiology of Aging Laboratory
Boulder, Colorado, 80309
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Time Restricted Feeding
- Keywords
- time restricted feeding, endothelial function, arterial stiffness, intermittent fasting
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted FeedingBehavioural
Also called TRF
consuming all daily calories within an 8 hour feeding window
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Time Restricted Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium Dependent Dilation
Brachial Artery Flow-Mediated Dilation (FMD)
Measured: 6 weeks
Secondary outcomes (4)
Arterial Stiffness
Aortic Pulse Wave Velocity (PWV)
Measured: 6 weeks
Cognitive Function
NIH Toolbox Cognitive Function Battery
Measured: 6 weeks
Motor Function
NIH Toolbox Motor Function Battery
Measured: 6 weeks
Metabolic Function
Oral glucose tolerance test (OGTT)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Principal investigator, Douglas Seals, University of Colorado, Boulder
- Investigators
- Christopher R Martens, Ph.D., Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970188
- Sponsor's protocol ID
- 15-0108
- Status last verified
- Jun 2019
- First submitted
- 18 Nov 2016
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults
- ClinicalTrials.gov ID
- NCT02970188
- Acronym / sponsor ID
- 15-0108
- Conditions
- Aging
- Keywords
- time restricted feeding, endothelial function, arterial stiffness, intermittent fasting
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- Apr 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Feeding | No intervention | –Subjects will be instructed to eat within their normal feeding window. |
| Time Restricted Feeding | Experimental | Behavioral: Time Restricted FeedingSubjects 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. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted FeedingAlso: TRFconsuming all daily calories within an 8 hour feeding window | Behavioural | Time Restricted Feeding |
Primary outcome
Endothelium Dependent Dilation
Time frame: 6 weeks
Brachial Artery Flow-Mediated Dilation (FMD)
4 secondary outcomes
Arterial Stiffness
Time frame: 6 weeks
Cognitive Function
Time frame: 6 weeks
Motor Function
Time frame: 6 weeks
Metabolic Function
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Derived from this study: PubMed 33512717Allaf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R Martens, Ph.D. principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Time Restricted Feeding in people with Aging, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelium Dependent Dilation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.