Clinical trial NCT06019195: The Effect of Intermittent Fasting on Brain Health
Official title: Time Restricted Eating for Prevention of Age-related Vascular Cognitive Decline in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intermittent Fasting
Aging
Keywords: Intermittent Fasting
Aging
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-31
Enrollment: 32
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
timeFrame: baseline, up to 6 months
measure: Change in neurovascular coupling using the dynamic retinal vessel analysis
timeFrame: baseline, up to 6 months
measure: Change in EEG spectra
timeFrame: baseline, up to 6 months
Secondary outcomes:
measure: Change in microvascular endothelial function
timeFrame: baseline, up to 6 months
measure: Change in arterial stiffness
timeFrame: baseline, up to 6 months
measure: Change in Glycocalyx - perfused boundary region
timeFrame: baseline, up to 6 months
measure: Change in capillary density
timeFrame: baseline, up to 6 months
measure: Change in red blood cell velocity
timeFrame: baseline, up to 6 months
measure: Change in Attention
timeFrame: baseline, up to 6 months
measure: Change in Working Memory
timeFrame: baseline, up to 6 months
measure: Change in Executive Function
timeFrame: baseline, up to 6 months
measure: Change in Processing Speed
timeFrame: baseline, up to 6 months
measure: Body composition
timeFrame: baseline, up to 6 months
measure: Dietary intakes
timeFrame: baseline, up to 6 months
measure: Total daily energy expenditure
timeFrame: baseline, up to 6 months
measure: Change in blood metabolic panel markers
timeFrame: baseline, up to 6 months
measure: Change in Episodic Memory
timeFrame: baseline, up to 6 months
measure: Change in Language
timeFrame: baseline, up to 6 months
measure: Change in BOLD signal
timeFrame: baseline, up to 6 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Translational GeroScience Laboratory
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Andriy Yabluchanskiy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: