Time Restricted EatingNCT05488652
Cerebromicrovascular Effects of Time-Restricted Eating in Older Adults
A study testing Time restricted eating in people with Time Restricted Eating, run by University of Oklahoma at 1 site in United States.
Trial summary
The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Eating
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥21 years
- Adequate hearing and visual acuity to participate in examinations
- Ability to read and write in English
- Competence to provide informed consent
Who cannot join
- Vision or hearing impairment that would impair the ability to complete study assessments
- Active CNS disease including multiple sclerosis, uncontrolled seizures, and active brain cancer
- Cerebrovascular accident other than TIA within 60 days prior to screening
- Any other medical condition which, in the opinion of the investigator, would render the participant inappropriate or too unstable to complete the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways.
Read the detailed description
This hypothesis will be tested by assessing the effect of TRE (not more than 10hr eating window each day for 6 months) in healthy adults (≥21 years of age).
- Conditions
- Time Restricted Eating
- Being tested
- Time restricted eating
- Keywords
- Time restricted eating, Intermittent fasting, neurovascular coupling, cognitive function, aging
- 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 eatingBehavioural
14:10 daily fasting regimen
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Experimental | 14 h of fasting daily (10 h of free eating) Receives: Behavioral: Time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurovascular Coupling Using Functional Near Infrared Spectroscopy (fNIRS)
Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated hemoglobin measured over the cortical brain tissues. fNIRS data is analyzed using a pipeline based on the General Linear Model (GLM) approach created using the Brain AnalyzIR toolbox and implemented in MatLab. At the subject level, regression coefficients (beta values) are extracted to characterize individual neurovascular coupling response in the prefrontal cortex across all n-back blocks. It is expected that more difficult cognitive tasks will lead to increased neurovascular coupling responses in healthy individuals, but no clinically relevant ranges exist for this measure.
Measured: Baseline, 6 months
Secondary outcomes (16)
Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis
Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). The change in retinal vessel diameters is tracked and reported as a %change from baseline, before and after treatment.
Measured: Baseline, 6 months
Neurovascular Coupling Using Transcranial Doppler
Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment.
Measured: Baseline, 6 months
Microvascular Endothelial Function
Changes in microvascular endothelial function will be assessed using laser speckle contrast imaging (LSCI) in the hand using the flow mediated dilation approach. The change in skin perfusion is calculated and reported as a fold change from baseline.
Measured: Baseline, 6 months
Macrovascular Endothelial Function
Changes in macrovascular endothelial function will be assessed using sonography during flow mediated dilation approach. The change in brachial artery diameter is calculated and reported as a %change from baseline.
Measured: Baseline, 6 months
Deep Tissue Oxygen Saturation
Transcutaneous deep tissue oxygen saturation will be measured using the inSpectra near infrared device. The data are calculated and reported as a %change from baseline.
Measured: Baseline, 6 months
Arterial Stiffness
The arterial stiffness will be measured using the pulse wave analysis approach (SphygmoCor, Atcor medical, Itasca IL, or similar). Analysis generated the augmentation index which will be used for comparison before and after treatment.
Measured: Baseline, 6 months
ECG
ECG will be recorded for heart rate variability analysis. The values of high frequency domain, low frequency domain, their ratio, as well as total power will be calculated and used for comparison before and after treatment.
Measured: Baseline, 6 months
Glycocalyx - Perfused Boundary Region
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include perfused boundary region (um), and will be used for comparison before and after treatment.
Measured: Baseline, 6 months
Capillary Density
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include capillary density (mm/mm^2), and will be used for comparison before and after treatment.
Measured: Baseline, 6 months
Red Blood Cell Velocity
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include red blood cell velocity (um/sec), and will be used for comparison before and after treatment.
Measured: Baseline, 6 months
Inhibitory Control and Attention
Flanker Inhibitory Control and Attention Test was used to assess inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes.
Measured: Baseline, 6 months
Episodic Memory
Picture Sequence Memory Test was used to assess episodic memory. Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented to them. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes.
Measured: Baseline, 6 months
Working Memory
List Sorting Working Memory Test was used to assess working memory. The participant is asked to recall and sequence different stimuli that are presented visually and via audio. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes.
Measured: Baseline, 6 months
Language
Picture Vocabulary Test measures receptive vocabulary administered in a computer-adaptive test (CAT) format. Respondents select the picture that most closely matches the meaning of the word. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes.
Measured: Baseline, 6 months
Executive Function
Dimensional Change Card Sort Test was used to assess cognitive flexibility and attention. The participant is asked to match a series of picture pairs to a target picture. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes.
Measured: Baseline, 6 months
Processing Speed
Pattern Comparison Processing Speed Test was used to assess processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start17 Nov 2022
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Time Restricted EatingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Tarantini, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488652
- Sponsor's protocol ID
- 14856
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2022
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebromicrovascular Effects of Time-Restricted Eating in Older Adults
- ClinicalTrials.gov ID
- NCT05488652
- Acronym / sponsor ID
- 14856
- Conditions
- Time Restricted Eating
- Keywords
- Time restricted eating, Intermittent fasting, neurovascular coupling, cognitive function, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways.
Detailed description
This hypothesis will be tested by assessing the effect of TRE (not more than 10hr eating window each day for 6 months) in healthy adults (≥21 years of age).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Behavioral: Time restricted eating14 h of fasting daily (10 h of free eating) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥21 years
- Adequate hearing and visual acuity to participate in examinations
- Ability to read and write in English
- Competence to provide informed consent
Key exclusion criteria (4 listed)
- Vision or hearing impairment that would impair the ability to complete study assessments
- Active CNS disease including multiple sclerosis, uncontrolled seizures, and active brain cancer
- Cerebrovascular accident other than TIA within 60 days prior to screening
- Any other medical condition which, in the opinion of the investigator, would render the participant inappropriate or too unstable to complete the study protocol
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 eating14:10 daily fasting regimen | Behavioural | Time restricted eating |
Primary outcome
Neurovascular Coupling Using Functional Near Infrared Spectroscopy (fNIRS)
Time frame: Baseline, 6 months
Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated hemoglobin measured over the cortical brain tissues. fNIRS data is analyzed using a pipeline based on the General Linear Model (GLM) approach created using the Brain AnalyzIR toolbox and implemented in MatLab. At the subject level, regression coefficients (beta values) are extracted to characterize individual neurovascular coupling response in the prefrontal cortex across all n-back blocks. It is expected that more difficult cognitive tasks will lead to increased neurovascular coupling responses in healthy individuals, but no clinically relevant ranges exist for this measure.
16 secondary outcomes
Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis
Time frame: Baseline, 6 months
Neurovascular Coupling Using Transcranial Doppler
Time frame: Baseline, 6 months
Microvascular Endothelial Function
Time frame: Baseline, 6 months
Macrovascular Endothelial Function
Time frame: Baseline, 6 months
Deep Tissue Oxygen Saturation
Time frame: Baseline, 6 months
Arterial Stiffness
Time frame: Baseline, 6 months
ECG
Time frame: Baseline, 6 months
Glycocalyx - Perfused Boundary Region
Time frame: Baseline, 6 months
Capillary Density
Time frame: Baseline, 6 months
Red Blood Cell Velocity
Time frame: Baseline, 6 months
Inhibitory Control and Attention
Time frame: Baseline, 6 months
Episodic Memory
Time frame: Baseline, 6 months
Working Memory
Time frame: Baseline, 6 months
Language
Time frame: Baseline, 6 months
Executive Function
Time frame: Baseline, 6 months
Processing Speed
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Stefano Tarantini, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Time Restricted Eating, run by University of Oklahoma 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 4 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: finished, as of the sponsor's last update on 17 Aug 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Neurovascular Coupling Using Functional Near Infrared Spectroscopy (fNIRS) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.