HypertensionALIGNNCT07634926
Early Time-Restricted Eating for Cardiovascular Health
A study testing Early Time-Restricted Eating (eTRE) in people with Hypertension and Breakfast Skipper, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Breakfast Skipper
- What is being tested?
- Early Time-Restricted Eating (eTRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
Yi Lin, PhD, 205.996.5876, yilin@uabmc.edu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hypertension, Breakfast Skipper
- Being tested
- Early Time-Restricted Eating (eTRE)
- Keywords
- Early Time-Restricted Eating, Circadian Rhythm, Hypertension, Breakfast Skipping, Cardiovascular Health
- Medical subject headings
- Hypertension, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time-Restricted Eating (eTRE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Early Time-Restricted Eating (eTRE) |
| Control group | No intervention | Participants in the control group will be instructed to maintain habitual eating patterns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Week 6, and Week 12 of the intervention
Secondary outcomes (1)
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.
Measured: Baseline (Week 0), Week 6, and Week 12 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Lin, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634926
- Sponsor's protocol ID
- IRB-300016105
- Other IDs
- 26CDA1600914
- Acronym
- ALIGN
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aligning Clocks: Time-Restricted Eating to Improve Cardiovascular Health in Hypertensive Older Adults Who Skip Breakfast
- ClinicalTrials.gov ID
- NCT07634926
- Acronym / sponsor ID
- ALIGN / IRB-300016105
- Conditions
- Hypertension, Breakfast Skipper
- Keywords
- Early Time-Restricted Eating, Circadian Rhythm, Hypertension, Breakfast Skipping, Cardiovascular Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early time-restricted eating (eTRE) group | Experimental | Behavioral: 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. |
| Control group | No intervention | –Participants in the control group will be instructed to maintain habitual eating patterns. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Early time-restricted eating (eTRE) group |
Primary outcome
24-Hour Systolic Blood Pressure
Time frame: 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.
1 secondary outcome
Flow-Mediated Dilation
Time frame: Baseline (Week 0), Week 6, and Week 12 of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time-Restricted Eating (eTRE) in people with Hypertension and Breakfast Skipper, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lin, PhD (205.996.5876, yilin@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-Hour Systolic Blood Pressure (time frame: Baseline (Week 0), Week 6, and Week 12 of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.