HypertensionNCT07135505
Early Time-Restricted Eating in Older Adults With Hypertension
A study testing Early time-restricted eating in people with Hypertension and Eating Behaviors, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Eating Behaviors
- What is being tested?
- Early time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 31 Jul 2028
- 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
- Consent to participate in the study
- Men and women ≥ 60 years old
- Average office systolic BP ≥130 mmHg
- Self-reported ≥12 hours eating period per day of at least 5 days/week
- Stable health history over the past 2 months
Who cannot join
- Fasting >12 hours per day
- Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
- Have lost ≥ 10 pounds in last 3 months
- Unable to wake up at a regular time between 6-8 am
- Perform overnight shift work more than 1day/week on average
- Resting heart rate of >120 beats per minute, systolic blood pressure > 180 mmHg and/or diastolic blood pressure of > 100 mmHg
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- 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)
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, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Yi Lin, PhD, 205-996-5876, yilin@uabmc.edu
Yi Lin, PhD
About this study
Official title: The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.
- Conditions
- Hypertension, Eating Behaviors
- Being tested
- Early time-restricted eating
- Medical subject headings
- Hypertension, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early time-restricted eatingBehavioural
The participants will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-8:30 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 |
|---|---|---|
| Intervention | Active comparator | Early time-restricted eating Receives: Behavioral: Early time-restricted eating |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
measured by the continuous glucose monitor
Measured: Baseline and 12 weeks
Heart rate variability
measured by the Holter monitor
Measured: Baseline and 12 weeks
Systolic Blood pressure
measured by the ambulatory blood pressure monitor
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start16 Feb 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Jul 2028 (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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- UAB Nutrition Obesity Research Center
- Responsible party
- Principal investigator, Yi Lin, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135505
- Sponsor's protocol ID
- IRB-300013053
- Other IDs
- UAB NORC Pilot Grant
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shared due to concerns regarding participant privacy and the sensitive nature of the health-related data collected.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window
- ClinicalTrials.gov ID
- NCT07135505
- Acronym / sponsor ID
- IRB-300013053
- Conditions
- Hypertension, Eating Behaviors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- UAB Nutrition Obesity Research Center
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 22 Aug 2025 (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.
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic 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 |
|---|---|---|
| Intervention | Active comparator | Behavioral: Early time-restricted eatingEarly time-restricted eating |
| Control | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consent to participate in the study
- Men and women ≥ 60 years old
- Average office systolic BP ≥130 mmHg
- Self-reported ≥12 hours eating period per day of at least 5 days/week
- Stable health history over the past 2 months
Key exclusion criteria (16 listed)
- Fasting >12 hours per day
- Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
- Have lost ≥ 10 pounds in last 3 months
- Unable to wake up at a regular time between 6-8 am
- Perform overnight shift work more than 1day/week on average
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 eatingThe participants will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-8:30 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 | Intervention |
Primary outcome
Blood glucose
Time frame: Baseline and 12 weeks
measured by the continuous glucose monitor
Heart rate variability
Time frame: Baseline and 12 weeks
measured by the Holter monitor
Systolic Blood pressure
Time frame: Baseline and 12 weeks
measured by the ambulatory blood pressure monitor
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 22 Jun 2026.
- Individual participant dataSharing planned: Undecided. IPD may not be shared due to concerns regarding participant privacy and the sensitive nature of the health-related data collected.
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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 in people with Hypertension and Eating Behaviors, 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 22 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Baseline and 12 weeks). The study lists 3 primary outcomes in all. 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 22 Jun 2026.