Cerebromikrovaskulære virkninger af tidsbegrænset spisning hos ældre voksne
25. juni 2026 opdateret af: University of Oklahoma
Den centrale hypotese i denne undersøgelse er, at tættere overholdelse af tidsbegrænset spisning (TRE) vil forbedre endotelfunktionen, neurovaskulære (NVC) responser, hvilket resulterer i forbedret kognitiv ydeevne, potentielt gennem aktivering af SIRT1-afhængige vasoprotektive veje.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Denne hypotese vil blive testet ved at vurdere effekten af TRE (ikke mere end 10 timers spisevindue hver dag i 6 måneder) hos raske voksne (≥21 år).
Gruppen af forsøgspersoner indskrevet i TRE-armen vil blive sammenlignet med kontrolgruppen.
Alle deltagere vil blive randomiseret i begge dele af undersøgelsen.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
11
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73117
- University of Oklahoma Health Sciences Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
-Raske voksne ≥21 år
Ekskluderingskriterier:
- Manglende evne til at læse eller skrive på engelsk
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Time restricted eating
14 h of fasting daily (10 h of free eating)
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14:10 daily fasting regimen
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Neurovascular Coupling Using Functional Near Infrared Spectroscopy (fNIRS)
Tidsramme: Baseline, 6 months
|
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.
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Baseline, 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis
Tidsramme: Baseline, 6 months
|
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.
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Baseline, 6 months
|
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Neurovascular Coupling Using Transcranial Doppler
Tidsramme: Baseline, 6 months
|
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.
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Baseline, 6 months
|
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Microvascular Endothelial Function
Tidsramme: Baseline, 6 months
|
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 fold change from baseline.
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Baseline, 6 months
|
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Macrovascular Endothelial Function
Tidsramme: Baseline, 6 months
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Changes in macrovascular endothelial function will be assessed using sonography during flow mediated dilation approach.
The change in brachial artery diameter is calculated and reported as a %change from baseline.
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Baseline, 6 months
|
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Deep Tissue Oxygen Saturation
Tidsramme: Baseline, 6 months
|
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.
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Baseline, 6 months
|
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Arterial Stiffness
Tidsramme: Baseline, 6 months
|
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 treatment.
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Baseline, 6 months
|
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ECG
Tidsramme: Baseline, 6 months
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ECG will be recorded for heart rate variability analysis.
The values of high frequency domain, low frequency domain, their ratio, as well as total power will be calculated and used for comparison before and after treatment.
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Baseline, 6 months
|
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Glycocalyx - Perfused Boundary Region
Tidsramme: Baseline, 6 months
|
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 treatment.
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Baseline, 6 months
|
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Capillary Density
Tidsramme: Baseline, 6 months
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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 treatment.
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Baseline, 6 months
|
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Red Blood Cell Velocity
Tidsramme: Baseline, 6 months
|
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, 6 months
|
|
Inhibitory Control and Attention
Tidsramme: Baseline, 6 months
|
Flanker Inhibitory Control and Attention Test was used to assess inhibitory control and attention.
The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
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Baseline, 6 months
|
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Episodic Memory
Tidsramme: Baseline, 6 months
|
Picture Sequence Memory Test was used to assess episodic memory.
Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented to them.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
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Working Memory
Tidsramme: Baseline, 6 months
|
List Sorting Working Memory Test was used to assess working memory.
The participant is asked to recall and sequence different stimuli that are presented visually and via audio.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
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Baseline, 6 months
|
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Language
Tidsramme: Baseline, 6 months
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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.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
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Baseline, 6 months
|
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Executive Function
Tidsramme: Baseline, 6 months
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Dimensional Change Card Sort Test was used to assess cognitive flexibility and attention.
The participant is asked to match a series of picture pairs to a target picture.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
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Baseline, 6 months
|
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Processing Speed
Tidsramme: Baseline, 6 months
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Pattern Comparison Processing Speed Test was used to assess processing speed.
Participants are asked to quickly determine whether two stimuli are the same or not the same.
Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10).
Higher scores represent better outcomes.
|
Baseline, 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Stefano Tarantini, PhD, University of Oklahoma
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. november 2022
Primær færdiggørelse (Faktiske)
10. januar 2024
Studieafslutning (Faktiske)
10. januar 2024
Datoer for studieregistrering
Først indsendt
22. juli 2022
Først indsendt, der opfyldte QC-kriterier
2. august 2022
Først opslået (Faktiske)
4. august 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14856
Plan for individuelle deltagerdata (IPD)
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