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Early Time-Restricted Eating for Cardiovascular Health (ALIGN)

3 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

36

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yi Lin, PhD
  • Número de teléfono: 205.996.5876
  • Correo electrónico: yilin@uabmc.edu

Ubicaciones de estudio

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35205
        • University of Alabama at Birmingham
        • Contacto:
          • Yi Lin, PhD
          • Número de teléfono: 205.996.5876
          • Correo electrónico: yilin@uabmc.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: 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.
Sin intervención: Control group
Participants in the control group will be instructed to maintain habitual eating patterns.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
24-Hour Systolic Blood Pressure
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Flow-Mediated Dilation
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Alabama at Birmingham

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

31 de marzo de 2029

Finalización del estudio (Estimado)

31 de agosto de 2029

Fechas de registro del estudio

Enviado por primera vez

3 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

9 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • IRB-300016105
  • 26CDA1600914 (Otro número de subvención/financiamiento: American Heart Association)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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