The Effect of Intermittent Fasting on Brain Health

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aging; Intermittent Fasting
• Intervention / Treatment: Other: Time restricted eating

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andriy Yabluchanskiy, MD, PhD; Phone Number: 47097 405-271-8000; Email: andriy-yabluchanskiy@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • Translational GeroScience Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, up to 6 months
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.	baseline, up to 6 months
Change in 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, between before and after completion of study.	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months
Body composition	Weight and body composition using a bioimpedance scale. Reported as a %change from baseline, before and after completion of study	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months
Change in blood metabolic panel markers	Complete metabolic panel. Reported as a %change from baseline, before and after completion of study	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months
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.	baseline, up to 6 months

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Andriy Yabluchanskiy, MD, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Aging; Intermittent Fasting
• Other Study ID Numbers: 16102; 1R21AG080775-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: unidentified data may be shared via research repositories

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No