NCT05488652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 17, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

August 17, 2026

Completed
Last Updated

August 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

July 22, 2022

Results QC Date

March 31, 2025

Last Update Submit

June 25, 2026

Conditions

Time Restricted Eating

Keywords

Time restricted eatingIntermittent fastingneurovascular couplingcognitive functionaging

Outcome Measures

Primary Outcomes (1)

  • 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 hemoglobin measured over the cortical brain tissues. fNIRS data is analyzed using a pipeline based on the General Linear Model (GLM) approach created using the Brain AnalyzIR toolbox and implemented in MatLab. At the subject level, regression coefficients (beta values) are extracted to characterize individual neurovascular coupling response in the prefrontal cortex across all n-back blocks. It is expected that more difficult cognitive tasks will lead to increased neurovascular coupling responses in healthy individuals, but no clinically relevant ranges exist for this measure.

    Baseline, 6 months

Secondary Outcomes (16)

  • Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis

    Baseline, 6 months

  • Neurovascular Coupling Using Transcranial Doppler

    Baseline, 6 months

  • Microvascular Endothelial Function

    Baseline, 6 months

  • Macrovascular Endothelial Function

    Baseline, 6 months

  • Deep Tissue Oxygen Saturation

    Baseline, 6 months

  • +11 more secondary outcomes

Study Arms (1)

Time restricted eating

EXPERIMENTAL

14 h of fasting daily (10 h of free eating)

Behavioral: Time restricted eating

Interventions

Time restricted eatingBEHAVIORAL

14:10 daily fasting regimen

Time restricted eating

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥21 years
  • Adequate hearing and visual acuity to participate in examinations
  • Ability to read and write in English
  • Competence to provide informed consent

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, and active brain cancer
  • Cerebrovascular accident other than TIA within 60 days prior to screening
  • Any other medical condition which, in the opinion of the investigator, would render the participant inappropriate or too unstable to complete the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Limitations and Caveats

Study limitations include: * Small sample size * High dropout rate * No male sex representation

Results Point of Contact

Title
Andriy Yabluchanskiy
Organization
University of Oklahoma Health Sciences Center
andriy-yabluchanskiy@ouhsc.edu
405-271-8001

Study Officials

  • Stefano Tarantini, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 22, 2022

First Posted

August 4, 2022

Study Start

November 17, 2022

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

August 17, 2026

Results First Posted

August 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)