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Early Time-Restricted Eating for Cardiovascular Health (ALIGN)

3. juni 2026 oppdatert av: Yi Lin, University of Alabama at Birmingham

Aligning Clocks: Time-Restricted Eating to Improve Cardiovascular Health in Hypertensive Older Adults Who Skip Breakfast

This study will examine whether eating earlier in the day within a consistent 8-hour eating window can improve heart and blood vessel health in older adults with high blood pressure who often skip breakfast. Participants will be randomly assigned to either follow an early time-restricted eating schedule or continue their usual eating habits for 12 weeks. Researchers will measure blood pressure, blood vessel function, and biological markers related to the body's internal clock and oxidative stress to better understand how meal timing affects cardiovascular health.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Aging is a major risk factor for cardiovascular disease, largely due to elevated blood pressure (BP) and endothelial dysfunction. These conditions are common in older adults and often coexist, and breakfast skipping has emerged as an additional contributor. Delaying the first meal creates misalignment between central and peripheral circadian rhythms that regulate vascular and metabolic processes. This misalignment alters cortisol patterns and impairs glucose and insulin responses, increasing inflammation and oxidative stress. These disturbances weaken endothelial function and disrupt vascular tone and diurnal BP rhythms, contributing to hypertension and underscoring the need for interventions that restore vascular health in older adults who skip or delay breakfast.

Early time-restricted eating (eTRE) is a promising strategy that aligns food intake with hormonal rhythms by shifting meals earlier in the day. eTRE may strengthen circadian rhythms, reduce oxidative stress, and improve cardiovascular function, yet its effects in older adults with hypertension remain understudied. This project will address this gap by implementing a 12-week eTRE to evaluate effects on vascular health and circadian rhythms and to explore participants' experiences with adopting eTRE.

Thirty-six adults aged 60 and older with breakfast-skipping behavior and hypertension (average daytime systolic BP ≥130 mmHg per AHA criteria) will be randomized to eTRE or control, with equal numbers of morning and evening chronotypes based on the Morningness-Eveningness Questionnaire. Cardiovascular outcomes will be assessed with 24-hour ambulatory BP monitoring and flow-mediated dilation. Fasting blood samples will be collected to measure circadian clock gene expression and redox biomarkers. To understand behavioral and perceptual factors, ten eTRE participants will join two focus groups (n=5 per group) to discuss changes in energy, sleep timing, and daily routines.

The central hypothesis is that eTRE will improve BP regulation and endothelial function, regardless of chronotype, by enhancing circadian alignment, restoring redox balance, and promoting greater daily structure. Findings from this pilot study will provide preliminary evidence for a future trial and guide strategies to improve cardiovascular health in older adults.

Studietype

Intervensjonell

Registrering (Antatt)

36

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • University of Alabama at Birmingham
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Men and women ≥ 60 years old
  • Average office systolic BP ≥130 mmHg5
  • Self-reported skipping breakfast for at least 3 days in the past 7 days
  • Identified as having a morning or evening chronotype according to the Morningness-Eveningness Questionnaire68
  • Stable health history over the past 2 months
  • Stable medication history over the past 2 months, as recommended by the primary provider
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Fasting >13 hours per day
  • Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
  • Resting heart rate of >120 beats/minute, systolic BP >180 and/or diastolic BP >100 mmHg
  • Have lost ≥ 10 pounds in last 3 months
  • Self-reported exercise over 90 min/week
  • Unable to wake up at a regular time between 6-9 am
  • Perform overnight shift work more than 1day/week on average
  • Have been diagnosed with diabetes
  • On insulin or diabetes medication
  • Unstable angina, heart attack or stroke in the past 3 months
  • Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
  • Pregnant or breastfeeding
  • Rheumatoid arthritis, Parkinson's disease or currently on dialysis
  • Current diagnosis of a major psychiatric condition that would impair study participation
  • Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease
  • Active treatment for cancer in the past year
  • Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
  • Diagnosed cognitive impairment
  • Unable to fast for 16 hours.
  • Any condition that in the opinion of the investigator would impair ability to participate in the trial

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Early time-restricted eating (eTRE) group
Participants in the eTRE group will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-9:30 am), 6 days/week for 12 weeks.
Atferdsmessig: Early Time-Restricted Eating (eTRE)
Participants in the eTRE group will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-9:30 am), 6 days/week for 12 weeks. Participants will be allowed to consume calorie-free beverages, sugar-free gum, and will be encouraged to drink plenty of water throughout the entire intervention period.
Ingen inngripen: Control group
Participants in the control group will be instructed to maintain habitual eating patterns.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
24-Hour Systolic Blood Pressure
Tidsramme: Baseline (Week 0), Week 6, and Week 12 of the intervention
Change in mean 24-hour systolic blood pressure measured using ambulatory blood pressure monitoring (ABPM). Blood pressure will be recorded over a 24-hour period to assess the effects of early time-restricted eating on blood pressure regulation.
Baseline (Week 0), Week 6, and Week 12 of the intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Flow-Mediated Dilation
Tidsramme: Baseline (Week 0), Week 6, and Week 12 of the intervention
Change in endothelial function assessed by brachial artery flow-mediated dilation (FMD) using ultrasound. FMD will be expressed as the change in brachial artery diameter following reactive hyperemia.
Baseline (Week 0), Week 6, and Week 12 of the intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

31. mars 2029

Studiet fullført (Antatt)

31. august 2029

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-300016105
  • 26CDA1600914 (Annet stipend/finansieringsnummer: American Heart Association)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in publications arising from this study will be shared. These data may include demographic characteristics, blood pressure measurements, flow-mediated dilation (FMD) assessments, and anthropometric measurements.

IPD-delingstidsramme

Starting Date Available: 09/01/2029 Ending Date Available: 08/31/2034

Tilgangskriterier for IPD-deling

De-identified data will be available to qualified researchers whose proposed use of the data has been approved by the study investigators. Access will be provided for research purposes that are consistent with the informed consent provided by study participants. Researchers may request access by contacting the Principal Investigator and may be required to sign a data use agreement prior to receiving the data. Data will be shared electronically through secure file transfer methods.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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