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OpenTrials
Completed

NCT Number: NCT06019195

The Effect of Intermittent Fasting on Brain Health

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.

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Translational GeroScience Laboratory

Oklahoma City, Oklahoma, 73117, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Time restricted eating

Other

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

Other names: intermittent fasting

Primary outcomes

  1. Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)

    Time frame: baseline, up to 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 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.

  2. Change in neurovascular coupling using the dynamic retinal vessel analysis

    Time frame: baseline, up to 6 months

    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.

  3. Change in EEG spectra

    Time frame: baseline, up to 6 months

    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.

Secondary outcomes

  1. Change in microvascular endothelial function

    Time frame: baseline, up to 6 months

    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.

  2. Change in arterial stiffness

    Time frame: baseline, up to 6 months

    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.

  3. Change in Glycocalyx - perfused boundary region

    Time frame: baseline, up to 6 months

    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.

  4. Change in capillary density

    Time frame: baseline, up to 6 months

    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.

  5. Change in red blood cell velocity

    Time frame: baseline, up to 6 months

    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.

  6. Change in Attention

    Time frame: baseline, up to 6 months

    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.

  7. Change in Working Memory

    Time frame: baseline, up to 6 months

    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.

  8. Change in Executive Function

    Time frame: baseline, up to 6 months

    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.

  9. Change in Processing Speed

    Time frame: baseline, up to 6 months

    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.

  10. Body composition

    Time frame: baseline, up to 6 months

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

  11. Dietary intakes

    Time frame: baseline, up to 6 months

    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.

  12. Total daily energy expenditure

    Time frame: baseline, up to 6 months

    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.

  13. Change in blood metabolic panel markers

    Time frame: baseline, up to 6 months

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

  14. Change in Episodic Memory

    Time frame: baseline, up to 6 months

    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.

  15. Change in Language

    Time frame: baseline, up to 6 months

    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.

  16. Change in BOLD signal

    Time frame: baseline, up to 6 months

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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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