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Completed

NCT Number: NCT05488652

Cerebromicrovascular Effects of Time-Restricted Eating 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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

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 adults (≥21 years of age).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥21 years
  • Adequate hearing and visual acuity to participate in examinations
  • Ability to read and write in English
  • Competence to provide informed consent

Exclusion criteria

  • 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

Treatment and study plan

Time restricted eating

Behavioral

14:10 daily fasting regimen

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis

    Time frame: Baseline, 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 treatment.

  2. Neurovascular Coupling Using Transcranial Doppler

    Time frame: Baseline, 6 months

    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.

  3. Microvascular Endothelial Function

    Time frame: Baseline, 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 fold change from baseline.

  4. Macrovascular Endothelial Function

    Time frame: Baseline, 6 months

    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.

  5. Deep Tissue Oxygen Saturation

    Time frame: Baseline, 6 months

    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.

  6. Arterial Stiffness

    Time frame: Baseline, 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 treatment.

  7. ECG

    Time frame: Baseline, 6 months

    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.

  8. Glycocalyx - Perfused Boundary Region

    Time frame: Baseline, 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 treatment.

  9. Capillary Density

    Time frame: Baseline, 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 treatment.

  10. Red Blood Cell Velocity

    Time frame: Baseline, 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.

  11. Inhibitory Control and Attention

    Time frame: Baseline, 6 months

    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.

  12. Episodic Memory

    Time frame: Baseline, 6 months

    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.

  13. Working Memory

    Time frame: Baseline, 6 months

    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.

  14. Language

    Time frame: Baseline, 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. 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.

  15. Executive Function

    Time frame: Baseline, 6 months

    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.

  16. Processing Speed

    Time frame: Baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2022
Registry last updated
Aug 17, 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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