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Intermittent FastingNCT06019195

The Effect of Intermittent Fasting on Brain Health

A study testing Time restricted eating in people with Intermittent Fasting and Aging, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 55 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Intermittent Fasting, Aging
What is being tested?
Time restricted eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
13 May 2024to 2 Feb 2026
Phase
Interventional
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥55 and ≤80 years of age
  • Adequate hearing and visual acuity to participate in the examinations
  • Ability to read and write in English
  • Competence to provide informed consent.
  • Mini Montreal Cognitive Assessment ≥12
  • Mini Nutritional Assessment ≥12

Who cannot join

  • Vision or hearing impairment that would impair the ability to complete study assessments
  • Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
  • Cerebrovascular accident other than TIA within 60 days prior to Visit 0
  • Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
  • Diabetics prescribed sulfonylureas, meglitinides, and insulin
  • Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Translational GeroScience Laboratory

    Oklahoma City, Oklahoma, 73117

Other trials in United States

About this study

Official title: Time Restricted Eating for Prevention of Age-related Vascular Cognitive Decline in Older Adults

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 older adults (55-80 years of age).

Being tested
Time restricted eating
Keywords
Intermittent Fasting, 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 eatingOther

    Also called intermittent fasting

    not more than 10 hrs. eating window daily goal for 6 months

Study groups in NCT06019195
Study groupRoleWhat they receive
Time restricted eatingExperimentalnot more than 10 hrs. eating window daily goal for 6 months
Receives: Other: Time restricted eating

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 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 and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after completion of study.

    Measured: baseline, up to 6 months

  2. Change in 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 completion of study.

    Measured: baseline, up to 6 months

  3. Change in EEG spectra

    EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after completion of study.

    Measured: baseline, up to 6 months

Secondary outcomes (16)

  1. Change in 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 %change from baseline, between before and after completion of study.

    Measured: baseline, up to 6 months

  2. Change in 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 completion of study.

    Measured: baseline, up to 6 months

  3. Change in 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 completion of study.

    Measured: baseline, up to 6 months

  4. Change in 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 completion of study.

    Measured: baseline, up to 6 months

  5. Change in 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, up to 6 months

  6. Change in Attention

    The allocation of one's limited capacities to deal with an abundance of environmental stimulation will be measured in a combined "Flanker Inhibitory Control and Attention Test".Units of measure - score (from 0 to 10, bigger number is better). Reported as a %change from baseline.

    Measured: baseline, up to 6 months

  7. Change in Working Memory

    The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information will be measured using the "List Sorting Working Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline.

    Measured: baseline, up to 6 months

  8. Change in Executive Function

    The capacity to plan, organize and monitor the executive of behaviors that are strategically directed in a goal-oriented manner will be measured using the "Dimensional Change Card Sort Test". Units of measure - score (from 0 to 10, bigger number is better). Reported as a %change from baseline.

    Measured: baseline, up to 6 months

  9. Change in Processing Speed

    Pattern Comparison Processing Speed Test assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. Units of measure - score (from 0 to 130, bigger number is better). Reported as a %change from baseline.

    Measured: baseline, up to 6 months

  10. Body composition

    Weight and body composition using a bioimpedance scale and/or DXA scan. Reported as a %change from baseline, before and after completion of study

    Measured: baseline, up to 6 months

  11. Dietary intakes

    Dietary intake data for 24-hour recalls will be collected and analyzed using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool, version 2022, developed by the National Cancer Institute (https://epi.grants.cancer.gov/asa24). Estimated dietary intakes will be used to determine whether a participant was in a hypocaloric, eucaloric, or hypercaloric state during the intervention.

    Measured: baseline, up to 6 months

  12. Total daily energy expenditure

    Total daily energy expenditure will be estimated using the Mifflin-St. Jeor equation. Estimated total daily energy expenditure will be used to determine whether a participant was in a hypocaloric, eucaloric, or hypercaloric state during the intervention.

    Measured: baseline, up to 6 months

  13. Change in blood metabolic panel markers

    Complete metabolic panel. Reported as a %change from baseline, before and after completion of study

    Measured: baseline, up to 6 months

  14. Change in Episodic Memory

    Cognitive processes involved in the acquisition, storage and retrieval of new information, will be measured using the "Picture Sequence Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline.

    Measured: baseline, up to 6 months

  15. Change in 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, before and after treatment. Unit of measure - overall score (bigger number is better). Reported as a %change from baseline.

    Measured: baseline, up to 6 months

  16. Change in BOLD signal

    Using fMRI, we will determine the changes in BOLD activation during standardized cognitive task. Reported as change in BOLD signal before and after intervention.

    Measured: baseline, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study start13 May 2024
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06019195
Sponsor's protocol ID
16102
Other IDs
1R21AG080775-01A1
Status last verified
Feb 2026
First submitted
24 Aug 2023
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: unidentified data may be shared via research repositories

Publications

  • da C Pinaffi-Langley AC, Szarvas Z, Peterfi A, Kaposzta Z, Mukli P, Shahriari A, Muranyi M, Pinto CB, Owens CD, Adams C, Karfonta B, Rohan M, Tarantini S, Yabluchanskiy A. Time-restricted eating for prevention of age-related vascular cognitive decline in older adults: A protocol for a single-arm open-label interventional trial. PLoS One. 2024 Dec 9;19(12):e0314871. doi: 10.1371/journal.pone.0314871. eCollection 2024.

    PubMed 39652561

  • da C Pinaffi-Langley AC, Pinto CB, Mukli P, Peterfi A, Kaposzta Z, Owens CD, Szarvas Z, Muranyi M, Adams C, Shahriari A, Balasubramanian P, Ungvari Z, Csiszar A, Conley S, Hord NG, Anderson L, Tarantini S, Yabluchanskiy A. Energy metabolism dysregulation, cerebrovascular aging, and time-restricted eating: Current evidence and proof-of-concept findings. PNAS Nexus. 2024 Nov 8;3(11):pgae505. doi: 10.1093/pnasnexus/pgae505. eCollection 2024 Nov.

    PubMed 39584020

Questions about this trial

What is this clinical trial studying?

A study testing Time restricted eating in people with Intermittent Fasting and Aging, 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 6 inclusion and 6 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 6 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS) (time frame: baseline, up to 6 months). The study lists 3 primary outcomes in all. 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 NCT06019195, which also lists 2 linked publications.

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 6 Feb 2026.

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