The Effect of Intermittent Fasting on Brain Health

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019195
• Other study ID #: 16102
• Secondary ID: 1R21AG080775-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: University of Oklahoma
• Contact: Andriy Yabluchanskiy, MD, PhD
• Phone: 405-271-8000
• Email: andriy-yabluchanskiy[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Intermittent Fasting

Intervention

Other:
• Time restricted eating
not more than 10 hrs. eating window daily goal for 6 months

Locations

Country	Name	City	State
United States	Translational GeroScience Laboratory	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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