The Effect of Intermittent Fasting on Brain Health

NCT06019195 | Completed

• 2 other identifiers: 161021R21AG080775-01A1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Aging

Keywords

Intermittent Fasting; Aging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Change in microvascular endothelial function

  baseline, up to 6 months

• Change in arterial stiffness

  baseline, up to 6 months

• Change in Glycocalyx - perfused boundary region

  baseline, up to 6 months

• Change in capillary density

  baseline, up to 6 months

• Change in red blood cell velocity

  baseline, up to 6 months

Study Arms (1)

Time restricted eating

EXPERIMENTAL

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

Other: Time restricted eating

Interventions

Time restricted eating OTHER

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

Also known as: intermittent fasting

Time restricted eating

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Translational GeroScience Laboratory

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (2)

• da C Pinaffi-Langley AC, Szarvas Z, Peterfi A, Kaposzta Z, Mukli P, Shahriari A, Muranyi M, Pinto CB, Owens CD, Adams C, Karfonta B, Rohan M, Tarantini S, Yabluchanskiy A. Time-restricted eating for prevention of age-related vascular cognitive decline in older adults: A protocol for a single-arm open-label interventional trial. PLoS One. 2024 Dec 9;19(12):e0314871. doi: 10.1371/journal.pone.0314871. eCollection 2024.

  PMID: 39652561 BACKGROUND

• da C Pinaffi-Langley AC, Pinto CB, Mukli P, Peterfi A, Kaposzta Z, Owens CD, Szarvas Z, Muranyi M, Adams C, Shahriari A, Balasubramanian P, Ungvari Z, Csiszar A, Conley S, Hord NG, Anderson L, Tarantini S, Yabluchanskiy A. Energy metabolism dysregulation, cerebrovascular aging, and time-restricted eating: Current evidence and proof-of-concept findings. PNAS Nexus. 2024 Nov 8;3(11):pgae505. doi: 10.1093/pnasnexus/pgae505. eCollection 2024 Nov.

  PMID: 39584020 BACKGROUND

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Andriy Yabluchanskiy, MD, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 31, 2023
• Study Start: May 13, 2024
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)