Early Time-Restricted Eating for Cardiovascular Health (ALIGN)
Aligning Clocks: Time-Restricted Eating to Improve Cardiovascular Health in Hypertensive Older Adults Who Skip Breakfast
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yi Lin, PhD
- Telefonní číslo: 205.996.5876
- E-mail: yilin@uabmc.edu
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35205
- University of Alabama at Birmingham
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Kontakt:
- Yi Lin, PhD
- Telefonní číslo: 205.996.5876
- E-mail: yilin@uabmc.edu
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Žádný zásah: Control group
Participants in the control group will be instructed to maintain habitual eating patterns.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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24-Hour Systolic Blood Pressure
Časové okno: Baseline (Week 0), Week 6, and Week 12 of the intervention
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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.
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Baseline (Week 0), Week 6, and Week 12 of the intervention
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Flow-Mediated Dilation
Časové okno: Baseline (Week 0), Week 6, and Week 12 of the intervention
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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.
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Baseline (Week 0), Week 6, and Week 12 of the intervention
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB-300016105
- 26CDA1600914 (Jiné číslo grantu/financování: American Heart Association)
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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