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
10

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
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

July 22, 2022

Last Update Submit

January 19, 2024

Conditions

Time Restricted Eating

Keywords

Time restricted eatingIntermittent fastingneurovascular couplingcognitive functionaging

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 treatment.

    baseline, up to 6 months

  • Change in neurovascular coupling using transcranial Doppler

    Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment.

    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 treatment. .

    baseline, up to 6 months

Secondary Outcomes (14)

  • Change in microvascular endothelial function

    baseline, up to 6 months

  • Change in macrovascular endothelial function

    baseline, up to 6 months

  • Change in deep tissue oxygen saturation

    baseline, up to 6 months

  • Change in arterial stiffness

    baseline, up to 6 months

  • Change in ECG

    baseline, up to 6 months

  • +9 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

no intervention

Time restricted eating

EXPERIMENTAL

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

Other: Time restricted eating

Interventions

Time restricted eatingOTHER

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

Time restricted eating

Eligibility Criteria

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

You may qualify if:

  • Healthy adults ≥21 years of age

You may not qualify if:

  • Inability to read or write in English

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

Study Officials

  • Stefano Tarantini, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
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

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)