The Effect of Intermittent Fasting on Brain Health

Sponsor
University of Oklahoma (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06019195
Collaborator
(none)
32
1
1
23
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Time restricted eating
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Time Restricted Eating for Prevention of Age-related Vascular Cognitive Decline in Older Adults
Anticipated Study Start Date :
Aug 31, 2023
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Time restricted eating

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

Other: Time restricted eating
not more than 10 hrs. eating window daily goal for 6 months
Other Names:
  • intermittent fasting
  • Outcome Measures

    Primary Outcome Measures

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

    1. Change in microvascular endothelial function [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 deep tissue oxygen saturation [baseline, up to 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, between before and after completion of study.

    3. Change in arterial stiffness [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.

    4. Change in Glycocalyx - perfused boundary region [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.

    5. Change in capillary density [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.

    6. Change in red blood cell velocity [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.

    7. Change in Attention [baseline, up to 6 months]

      CANTAB research attention test.Reported as a %change from baseline, before and after completion of study.

    8. Change in Working Memory [baseline, up to 6 months]

      CANTAB research working memory test.Reported as a %change from baseline, before and after completion of study.

    9. Change in Executive Function [baseline, up to 6 months]

      CANTAB research executive function test.Reported as a %change from baseline, before and after completion of study.

    10. Change in Processing Speed [baseline, up to 6 months]

      CANTAB research processing speed test.Reported as a %change from baseline, before and after completion of study

    11. Body composition [baseline, up to 6 months]

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

    12. Dietary intakes [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.

    13. Total daily energy expenditure [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.

    14. Change in blood metabolic panel markers [baseline, up to 6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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-Mental State Exam score ≥24

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Translational GeroScience Laboratory Oklahoma City Oklahoma United States 73117

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT06019195
    Other Study ID Numbers:
    • temp749424
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Oklahoma

    Study Results

    No Results Posted as of Sep 7, 2023