- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05488652
Cerebromikrovaskulära effekter av tidsbegränsat ätande hos äldre vuxna
25 juni 2026 uppdaterad av: University of Oklahoma
Den centrala hypotesen för denna studie är att närmare efterlevnad av tidsbegränsat ätande (TRE) kommer att förbättra endotelfunktionen, neurovaskulära (NVC) svar, vilket resulterar i förbättrad kognitiv prestation, potentiellt genom aktivering av SIRT1-beroende vasoskyddande vägar.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Denna hypotes kommer att testas genom att bedöma effekten av TRE (inte mer än 10 timmars matfönster varje dag i 6 månader) hos friska vuxna (≥21 år).
Gruppen av försökspersoner inskrivna i TRE-armen kommer att jämföras med kontrollgruppen.
Alla deltagare kommer att randomiseras till endera delen av studien.
Studietyp
Interventionell
Inskrivning (Faktisk)
11
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73117
- University of Oklahoma Health Sciences Center
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Beskrivning
Inklusionskriterier:
- Friska vuxna ≥21 år
Exklusions kriterier:
- Oförmåga att läsa eller skriva på engelska
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neurovascular Coupling Using Functional Near Infrared Spectroscopy (fNIRS)
Tidsram: 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.
|
Baseline, 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis
Tidsram: 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.
|
Baseline, 6 months
|
|
Neurovascular Coupling Using Transcranial Doppler
Tidsram: 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.
|
Baseline, 6 months
|
|
Microvascular Endothelial Function
Tidsram: 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
|
|
Macrovascular Endothelial Function
Tidsram: Baseline, 6 months
|
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.
|
Baseline, 6 months
|
|
Deep Tissue Oxygen Saturation
Tidsram: 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.
|
Baseline, 6 months
|
|
Arterial Stiffness
Tidsram: 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
Tidsram: Baseline, 6 months
|
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.
|
Baseline, 6 months
|
|
Glycocalyx - Perfused Boundary Region
Tidsram: 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.
|
Baseline, 6 months
|
|
Capillary Density
Tidsram: 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 capillary density (mm/mm^2), and will be used for comparison before and after treatment.
|
Baseline, 6 months
|
|
Red Blood Cell Velocity
Tidsram: 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
Tidsram: 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.
|
Baseline, 6 months
|
|
Episodic Memory
Tidsram: 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
|
|
Working Memory
Tidsram: 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.
|
Baseline, 6 months
|
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Language
Tidsram: Baseline, 6 months
|
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
Tidsram: Baseline, 6 months
|
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.
|
Baseline, 6 months
|
|
Processing Speed
Tidsram: Baseline, 6 months
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Stefano Tarantini, PhD, University of Oklahoma
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
17 november 2022
Primärt slutförande (Faktisk)
10 januari 2024
Avslutad studie (Faktisk)
10 januari 2024
Studieregistreringsdatum
Först inskickad
22 juli 2022
Först inskickad som uppfyllde QC-kriterierna
2 augusti 2022
Första postat (Faktisk)
4 augusti 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14856
Plan för individuella deltagardata (IPD)
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