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| ID | Type | Description | Link |
|---|---|---|---|
| 26CDA1600914 | Other Grant/Funding Number | American Heart Association |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early time-restricted eating (eTRE) group | Experimental | 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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| Control group | No Intervention | Participants in the control group will be instructed to maintain habitual eating patterns. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Time-Restricted Eating (eTRE) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-Hour Systolic Blood Pressure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Flow-Mediated Dilation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Lin, PhD | Contact | 205.996.5876 | yilin@uabmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States |
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.
Starting Date Available: 09/01/2029 Ending Date Available: 08/31/2034
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.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
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| D001519 |
| Behavior |